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U.S. Department of Health and Human Services

Enforcement Report - Week of May 22, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Fresh Frozen Plasma (Apheresis) 71X52474 part 1 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. LifeSouth Community Blood Centers, Inc.
Biologics Source Plasma 372096384; 372095334; 372094672; 372093645; 372093052; 372092045; 372090293; 372088790; 372088180; 372087073; 372086472; 372085212; 372084648; 372082085; 372081677; 372080542; 372077876; 372077265; 372075681; 372075140; 372073882; 372073290; 372071702; 372071102; 372069488; 372067904; 372067296; 372066247; 372065681; 372064593; 372063947; 372062884; 372062252; 372059770; 372059081; 372057615; 372056898; 372055988; 372055497; 372054548; 372053473; 372049013; 372048030 Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. Talecris Plasma Resources, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 4663295- part 1 & 2; 4663335- part 1 & 2; 4663316- part 1 & 2; 4664074- part 1 & 2; 4664066- part 1 & 2; 4664042- part 1; 4664053- part 2; 4664223-part 1 & 2 ; 4664230- part 1 & 2; 4666036- part 1 & 2; 4663143- part 1 & 2; 4663162- part 1 & 2; 4664236- part 1 & 2 Class II Blood products, which were not manufactured in accordance to acceptable product specifications, were distributed. Northwest Florida Blood Center, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated 4663294- part 1 & 2 Class II Blood products, which were not manufactured in accordance to acceptable product specifications, were distributed. Northwest Florida Blood Center, Inc.
Biologics Source Plasma 02IIAA7720 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells 6303489 Class III Blood product, collected from a donor whose arm inspection was not performed, was distributed. BloodNetUSA, Inc.
Biologics Blood and Blood Products for Reprocessing 6303489 Class III Blood product, collected from a donor whose arm inspection was not performed, was distributed. BloodNetUSA, Inc.
Biologics Red Blood Cells 25FG53377; 25FR30134; Class II Blood products, collected from a deferred donor, were distributed. American National Red Cross (The)
Biologics Platelets 25FR30134; 25KK27769 Class II Blood products, collected from a deferred donor, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma 4503686 Class II Blood products, collected from a donor who was previously deferred for being at increased risk for vCJD, were distributed. The Blood Alliance, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated 021LE24198. Class III Blood products, collected using expired blood collection sets, were distributed. American National Red Cross (The)
Biologics Plasma Frozen 021LE24188, 021LM25906, 021LM25915, 021LM25918, 21LE24195, 021LE24211, 021LM25920. Class III Blood products, collected using expired blood collection sets, were distributed. American National Red Cross (The)
Biologics Red Blood Cell Leukocytes Reduced 021LM25919, 021LE24330, 021LE24332, 021LM25913, 021LM25917, 021LM25911, 021LM25914, 021LE24200, 021LE24187, 021LE24189, 021LE24329, 021LM25924, 021LE24331, 021LE24335, 021LE24338, 021LE24346, 021LM25906, 021LM25908, 021LM25915, 021LM25916, 021LM25918, 021LM25921, 021LM25922, 021LM25930, 021LM25932, 021LM25934, 021LE24214, 021LE24217, 021LE24188, 021LM25929, 21LE24345, 21LE24205, 021LE24191, 021LE24192, 021LE24349, 021LE24351, 021LE24352, 021LE24355, 021LE24209, 021LE24211, 021LE24216, 021LE24190, 021LE24207, 021LE24210, 021LE24343, 021LM25920, 21LE24213, 21LE24195, 21LE24188, 021LE24184, 021LE24186, 021LE24334, 021LE24341, 021LE24342, 021LE24182, 021LE24354, 021LE24199, 021LE24206, 021LE24183, 021LE24208, 021LE24340, 021LM25931, 021LM25935, 021LE24215, 021LE24344. Class III Expired Blood bags used. American National Red Cross (The)
Biologics Source Plasma JK0182128 Class II Blood products, collected from a donor who admitted to high risk behavior, were distributed. DCI Biologicals Orlando LLC
Biologics Source Plasma OL0107985; OL0108176; OL0108514; OL0108652; OL0109051 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. DCI Biologicals Orlando LLC
Biologics Blood and Blood Products for Reprocessing 20LQ15418 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 20LQ15418 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 6864613 Class III Blood products, collected from a donor who was previously deferred for positive HIV test results, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells Leukocytes Reduced 6864613 Class II Blood products, collected from a donor who was previously deferred for positive HIV test results, were distributed. Community Blood Center of the Ozarks
Biologics Blood and Blood Products for Reprocessing 20FM43725 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced 20FM43725 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross
Biologics Blood and Blood Products for Reprocessing 181799600, 184284750 Class II Blood products, collected from a donor who reported testing positive for hepatitis, were distributed. Blood Systems Inc
Biologics Red Blood Cells Leukocytes Reduced 181799600, 184284750 Class II Blood products, collected from a donor who reported testing positive for hepatitis, were distributed. Blood Systems Inc
Biologics Platelets Pheresis Leukocytes Reduced 4573208A; 4573208C Class II Blood products, which did not meet the acceptable product specifications, were distributed. Florida Blood Services, Inc.
Biologics Source Plasma LR0305957; LR0306663 Class II Blood products, which were not quarantined subsequent to receiving information regarding post donation information, were distributed. DCI Biologicals Little Rock LLC
Biologics Source Plasma 366065365; 366065430; 366072465; 366074312; 366074666; 366081860; 366082295; 366083644; 366084122; 366088258; 366088678; 366090707; 366094116; 366094786; 366095612; 366096515; 366097322; 366098286; 366100123; 366100862; 366101853; 366102646; 366104664; 366104927; 366116229; 366120216; 366120573; 366121478; 366121828; 366123272; 377127087 Class II Blood products, collected from a donor who received a body piercing within 12 months of donation, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 366089959; 366089995 Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. Talecris Plasma Resources, Inc.
Food Hokkai Frozen Half Shell Oyster, 144 pcs/case. No codes. Class II The product has been prepared, packed, or held under insanitary conditions wherby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Hong Chang Corporation
Food Hokkai Tiny Oyster Meat I.Q.F., 40x8 oz No codes. Class II The product has been prepared, packed, or held under insanitary conditions wherby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Hong Chang Corporation
Food Hokkai Medium/Large Size Oyster Meat I.Q.F., 4 lbs x 6. No codes. Class II The product has been prepared, packed, or held under insanitary conditions wherby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Hong Chang Corporation
Food Hokkai Large Size Oyster Meat I.Q.F., 1 lb x 20, 3 lbs x 8, 1 lb x 30. No codes. Class II The product has been prepared, packed, or held under insanitary conditions wherby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Hong Chang Corporation
Biologics Source Plasma Q19486, Q19487, Q19488, Q19490 Class III Blood products untested for HIV and HCV by NAT were distributed. Blood and Plasma Research, Inc.
Biologics Red Blood Cells Leukocytes Reduced W045008039358; W045008115056; W045009058101 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Community Blood Center Of Gtr KC
Biologics Fresh Frozen Plasma W045008039358; W045008115056; W045009058101 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Community Blood Center Of Gtr KC
Biologics Platelets Pheresis Leukocytes Reduced W045006901629 Part 1;W045006901629 Part 2 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Community Blood Center Of Gtr KC
Biologics Source Plasma 5090011060 5090010338 5090019665 5090019435 5090017266 5090016755 5090016499 5090013137 5090012145 5090010621 5090009573 5090019647 5090019305 5090018810 5090018523 5090018545 5090017961 5090016116 5090025472 5090024995 5090023820 5090023303 5090017822 5090017009 5090016695 5090015129 5090014746 5090027102 5090026966 5090023844 5090023460 5090022964 5090021841 5090019671 5090019323 5090018846 5090018518 5090017967 5090017511 5090017149 5090015286 5090014719 5090014044 5090025510 5090025051 5090024528 5090024156 5090023662 5090023409 5090022849 5090022500 5090022051 5090021751 5090021244 5090020947 5090020426 5090019963 5090019534 5090018965 5090018790 5090018154 5090017938 5090017423 5090017089 5090016643 5090016309 5090015801 5090015405 5090015094 5090014544 5090013529 5090013235 5090012813 5090012533 5090012121 5090011571 5090010944 5090010503 5090010113 5090009894 5090019085 5090018625 5090017594 5090017298 5090017750 5090014247 5090013229 5090019211 5090018819 5090018370 5090018032 5090012959 5090010646 5090019135 5090018867 5090014895 5090020605 5090020277 5090019645 5090019418 5090018607 5090016943 5090016336 5090015929 5090011270 5090010680 5090020155 5090018961 5090018767 5090022573 5090021411 5090013972 5090013713 5090013308 5090016958 5090016422 5090015988 5090012477 5090011395 5090011209 5090010719 5090010354 5090009919 5090009679 5090013017 5090012624 5090011547 5090011135 5090026400 5090026294 5090016739 5090016255 5090015936 5090015200 5090024650 5090024382 5090022061 5090020181 5090019664 5090018711 5090027826 5090025313 5090024028 5090023365 5090023022 5090015927 5090012216 5090023362 5090022859 5090021749 5090020846 5090020405 5090019560 5090018999 5090017832 5090017382 5090024411 5090023887 5090022638 5090022198 5090021892 5090021332 5090021019 5090017493 5090017166 5090021810 5090020902 5090020566 5090020114 5090019594 5090019147 5090018658 5090018268 5090017819 5090017139 5090011195 5090012570 5090012273 5090011907 5090011473 5090010259 5090009533 5090001548 5090000948 5090000547 5090000309 5090000265 5090000185 5090020577 5090019691 5090019399 5090018836 5090018556 5090018020 5090017711 5090017161 5090016935 5090016450 5090016126 5090015626 5090015306 5090014837 5090014649 5090023056 5090022757 5090019785 5090018112 5090015263 5090014941 5090013812 5090013149 5090015482 5090015207 5090014762 5090014522 5090014099 5090014458 5090014031 5090018728 5090018152 5090017842 5090029175 5090028915 5090028335 5090028006 5090027298 5090027037 5090015127 5090014867 5090019314 5090018894 5090018575 5090016144 5090015797 5090015388 5090017765 5090017082 5090016796 5090016175 5090015819 5090015407 5090022569 5090015842 5090015247 5090014538 5090014070 5090013359 5090018504 5090018030 5090017279 5090016984 5090016329 5090016082 5090022476 5090022158 5090017702 5090016920 5090016433 5090016094 5090015600 5090019406 5090018916 5090018557 5090017595 5090017072 5090016459 5090015729 5090015525 5090019358 5090016380 5090016086 5090013876 5090012321 5090011876 5090022080 5090021572 5090018783 5090017879 5090014165 5090021436 5090019793 5090018890 5090014711 5090013272 5090012153 5090011906 5090018770 5090017413 5090016806 5090016304 5090015822 5090015229 5090015029 5090014442 5090026337 5090025955 5090025545 5090019027 5090018001 5090017762 5090017069 5090016066 5090015774 5090015315 5090015049 5090014443 5090014212 5090013720 5090013340 5090023980 5090023761 5090023021 5090022543 5090020703 5090018788 5090018404 5090017856 5090017499 5090016253 5090015954 5090015496 5090015163 5090014759 5090013647 5090013335 5090012716 5090011886 5090014758 5090015202 5090015832 5090016142 5090017062 5090018475 5090019601 5090020283 5090020904 5090021474 5090022384 5090022587 5090023212 5090024250 5090024880 5090025138 5090025461 5090026248 5090027687 5090026464 5090026170 5090024852 5090024579 5090023637 5090023405 5090022656 5090021863 5090021201 5090020849 5090020032 5090019332 5090018845 5090018203 5090017717 5090017323 5090016735 5090016379 5090015947 5090015701 5090028852 5090028546 5090028292 5090027705 5090027166 5090026860 5090026515 5090026231 5090025494 5090025064 5090024731 5090024247 5090023700 5090023378 5090022340 5090022064 5090021414 5090020892 5090019916 5090019438 5090018483 5090018251 5090017398 5090016592 5090015802 5090015296 5090015081 5090014632 5090014362 5090013655 5090012924 5090012235 5090011673 5090010909 5090022612 5090020812 5090020154 5090019105 5090018857 5090018324 5090016833 5090016325 5090016037 5090014810 5090013853 5090013401 5090013133 5090011389 5090011115 5090010718 5090010351 5090009916 5090009673 5090030095 5090029513 5090029306 5090028937 5090028746 5090028374 5090028044 5090027797 5090027502 5090027127 5090026944 5090026671 5090026436 5090026196 5090025909 5090025482 5090025027 5090024692 5090024138 5090023861 5090023308 5090021719 5090021348 5090020782 5090020470 5090019958 5090018922 5090018631 5090017910 5090017622 5090024257 5090022589 5090021794 5090020116 5090019613 5090018482 5090017611 5090016817 5090016023 5090015771 5090026630 5090026427 5090026123 5090025813 5090025396 5090024970 5090019459 5090019096 5090018657 5090018396 5090027121 5090026383 5090026079 5090025703 5090024666 5090024127 5090023760 5090023314 5090022501 5090021747 5090019194 5090018360 5090018017 5090017535 5090017218 5090030237 5090029956 5090029773 5090029533 5090026186 5090024387 5090023805 5090014282 5090014062 5090015973 5090016245 5090016878 5090017180 5090017674 5090017991 5090018535 5090018852 5090019763 5090020249 5090020578 5090021678 5090023198 5090023267 5090024173 5090026096 5090026387 5090026775 5090009374 5090010021 5090010076 5090010673 5090012654 5090013617 5090016521 5090016748 5090022402 5090024934 5090013931 5090014130 5090014770 5090015045 5090022233 5090022525 5090023043 5090023424 5090028698 5090029058 5090029415 5090029764 5090030259 5090029990 5090029055 5090027812 5090026646 5090025788 5090025209 5090024293 5090023098 5090021472 5090020652 5090019805 5090018668 5090017806 5090017275 5090016237 5090024895 5090024322 5090023813 5090023485 5090022958 5090022693 5090022217 5090021912 5090021396 5090021036 5090020526 5090020196 5090019677 5090019252 5090018869 5090018381 5090018005 5090017498 5090017153 5090016747 5090016365 5090015916 5090015620 5090015151 5090014920 5090013752 5090013495 5090013042 5090012730 5090029739 5090029496 5090029176 5090028362 5090027785 5090027114 5090026857 5090026664 5090026312 5090024858 5090024475 5090023977 5090023615 5090023092 5090022768 5090022298 5090022045 5090021584 5090021159 5090020541 5090020089 5090019489 5090018977 5090018742 5090018159 5090017813 5090017291 5090016985 5090016557 5090016272 5090015755 5090015476 5090015011 5090014741 5090013993 5090013577 5090013310 5090012250 5090028925 5090028625 5090028384 5090027998 5090027732 5090027461 5090027248 5090027086 5090026830 5090026642 5090026274 5090025987 5090024229 5090020510 5090020289 5090019437 5090019066 5090018062 5090015750 5090015522 5090014793 5090014529 5090013221 5090020893 5090018095 5090017782 5090017233 5090016842 5090016234 5090015925 5090015485 5090015184 5090014768 5090014450 5090013985 5090013307 5090013030 5090012651 5090029629 5090029102 5090028538 5090027969 5090027681 5090027435 5090027026 5090026518 5090025874 5090041179 5090040193 5090039837 5090038074 5090037876 5090028673 5090028505 5090027483 5090027273 5090027069 5090026903 5090026636 5090026435 5090026124 5090025816 5090025409 5090025019 5090024464 5090024128 5090023664 5090023311 5090022819 5090022469 5090021774 5090021551 5090020926 5090020394 5090020110 5090018472 5090018296 5090017597 5090017290 5090016827 5090016632 5090016004 5090015816 5090015223 5090015003 5090014560 5090014292 5090013842 5090013114 5090012405 5090012239 5090011697 5090010852 5090010694 5090010188 5090009971 5090010523 5090010317 5090009596 5090013180 5090013434 5090014089 5090029227 5090026411 5090026142 5090025699 5090024840 5090024541 5090023996 5090023713 5090022884 5090022094 5090021776 5090021182 5090020685 5090020424 5090019849 5090019557 5090018987 5090018710 5090018180 5090017720 5090017053 5090016745 5090016153 5090015560 5090022372 5090021643 5090021554 5090020813 5090019989 5090019651 5090019117 5090018879 5090018323 5090018058 5090017458 5090016995 5090016191 5090015879 5090015429 5090015110 5090014700 5090014412 5090013974 5090013708 5090013261 5090012987 5090012554 5090012281 5090011861 5090011554 5090011117 5090010791 5090010057 5090009885 5090022977 5090022618 5090022182 5090021832 5090021338 5090021048 5090020598 5090020159 5090019738 5090019447 5090017585 5090017236 5090016669 5090014531 5090016267 5090014673 5090013318 5090024943 5090024558 5090023917 5090023641 5090023162 5090022872 5090022373 5090022019 5090021484 5090021265 5090020746 5090020095 5090019822 5090019241 5090018613 5090018232 5090020329 5090019331 5090017653 5090025623 5090024761 5090024440 5090023972 5090023674 5090023055 5090022755 5090022181 5090021826 5090021284 5090020981 5090020325 5090019986 5090019563 5090019166 5090018622 5090018040 5090019338 5090018690 5090017663 5090016871 5090012046 5090011165 5090011243 5090010955 5090010213 5090009776 5090016616 5090016287 5090015696 5090015383 5090014237 5090013963 5090013520 5090013015 5090019636 5090018626 5090017934 5090016327 5090016025 5090015025 5090029109 5090025755 5090025376 5090024706 5090023746 5090023117 5090022895 5090022231 5090021921 5090021252 5090020445 5090020113 5090019280 5090018473 5090018078 5090017608 5090017086 5090016301 5090016009 5090014987 5090014797 5090013783 5090013582 5090012853 5090012163 5090020330 5090019357 5090016071 5090012954 5090025727 5090025356 5090024490 5090024097 5090022767 5090022142 5090021821 5090021291 5090020970 5090020167 5090019513 5090022336 5090021996 5090019705 5090019316 5090016001 5090015245 5090015056 5090014068 5090013807 5090013350 5090013044 5090020666 5090020179 5090019886 5090019333 5090018969 5090018527 5090018164 5090017684 5090017283 5090016856 5090016515 5090016054 5090015733 5090015295 5090014976 5090014433 5090014316 5090021067 5090015357 5090020035 5090019771 5090018059 5090017768 5090016140 5090015779 5090015165 5090014864 5090014523 5090014207 5090028587 5090028391 5090028066 5090027821 5090027224 5090025742 5090025360 5090024919 5090024079 5090023584 5090023010 5090022562 5090022175 5090021716 5090021106 5090020754 5090019778 5090028495 5090025012 5090023670 5090023237 5090022707 5090022415 5090021473 5090019883 5090018955 5090018761 5090018155 5090017645 5090017176 5090016969 5090016472 5090016170 5090015280 5090014841 5090014617 5090027337 5090026986 5090026365 5090026120 5090025799 5090025387 5090024964 5090024446 5090024103 5090023599 5090023272 5090022453 5090021987 5090021648 5090020809 5090020419 5090019982 5090019106 5090018651 5090018321 5090017793 5090017512 5090026802 5090026489 5090026105 5090025738 5090025369 5090024158 5090023402 5090023188 5090022020 5090021335 5090020669 5090020381 5090019726 5090019223 5090018517 5090017994 5090014238 5090013615 5090013068 5090012925 5090025869 5090025071 5090022053 5090021207 5090020596 5090020234 5090022891 5090021427 5090005652 5090005350 5090004584 5090004454 5090021951 5090016776 5090016113 5090015377 5090011783 5090014483 5090014163 5090018694 5090018181 5090016907 5090014909 5090010697 5090010382 5090010012 5090009697 5090012127 5090011860 5090011159 5090018458 5090017921 5090017601 5090016011 5090027805 5090022334 5090021745 5090020869 5090020649 5090020058 5090019844 5090019197 5090019009 5090016998 5090015143 5090014849 5090014419 5090013429 5090013164 5090012724 5090012036 5090011719 5090011006 5090019270 5090018697 5090019983 5090019502 5090025820 5090025406 5090025111 5090024911 5090023884 5090023348 5090022987 5090022512 5090021896 5090021360 5090020868 5090020612 5090020092 5090019477 5090018082 5090017559 5090017182 5090016688 5090016340 5090015918 5090015333 5090014821 5090014605 5090032871 5090031175 5090030256 5090029637 5090025290 5090024745 5090024232 5090022213 5090021397 5090020343 5090019533 5090019165 5090018799 5090024186 5090023008 5090022204 5090021926 5090021339 5090021023 5090020513 5090020232 5090019663 5090018883 5090018574 5090018028 5090017655 5090017179 5090026819 5090026319 5090025732 5090025354 5090024223 5090023824 5090023386 5090022952 5090022557 5090022195 5090021765 5090021353 5090020913 5090020536 5090020077 5090019715 5090019244 5090018871 5090018439 5090018015 5090017575 5090017151 5090016781 5090016406 5090015987 5090015619 5090015217 5090013943 5090036417 5090035407 5090035213 5090034387 5090024407 5090012114 5090011832 5090042269 5090042039 5090041455 5090028264 5090027800 5090027314 5090025379 5090022854 5090021146 5090018655 5090016257 5090015641 5090015949 5090015474 5090032340 5090032114 5090031827 5090031374 5090031185 5090030729 5090030504 5090030162 5090029879 5090029648 5090029318 5090029081 5090028729 5090028511 5090028165 5090027933 5090027611 5090027410 5090025734 5090025372 5090024877 5090024532 5090023985 5090023704 5090023201 5090022874 5090022348 5090022052 5090021559 5090021173 5090020717 5090020416 5090019892 5090019556 5090018205 5090017885 5090017344 5090017026 5090013487 5090018446 5090016463 5090014069 5090013503 5090024120 5090022830 5090018740 5090030796 5090030483 5090030115 5090029598 5090029373 5090029018 5090028804 5090028483 5090028281 5090027982 5090033333 5090028086 5090023527 5090021367 5090020829 5090019740 5090030307 5090025061 5090024721 5090024153 5090023910 5090022787 5090022503 5090021214 5090020690 5090019053 5090018377 5090015199 5090014889 5090014231 5090013892 5090013494 5090011086 5090008042 5090007360 5090020498 5090019126 5090018664 5090017312 5090027620 5090027399 5090026188 5090020907 5090019616 5090018909 5090018409 5090018063 5090017372 5090016905 5090016399 5090015977 5090015649 5090015038 5090012110 5090035266 5090034950 5090034749 5090034309 5090034011 5090033803 5090033483 5090033250 5090032906 5090032718 5090032382 5090032177 5090031664 5090031325 5090031126 5090030567 5090030211 5090029917 5090029759 5090029347 5090029133 5090027403 5090026822 5090026305 5090036810 5090036525 5090036024 5090034910 5090034500 5090034177 5090031740 5090012057 5090011801 5090011081 5090010454 5090015908 5090014856 5090014658 5090037695 5090035938 5090035604 5090035415 5090033439 5090033067 5090030642 5090030278 5090028799 5090028572 5090036726 5090036408 5090036220 5090032433 5090030502 5090029992 5090029729 5090029190 5090028932 5090028609 5090028339 5090028042 5090027748 5090027503 5090027290 5090027118 5090026950 5090026668 5090026422 5090025835 5090025451 5090025141 5090024748 5090024354 5090023853 5090023531 5090022974 5090022664 5090022013 5090021673 5090021190 5090020699 5090020435 5090019899 5090019353 5090018013 5090017736 5090034161 5090033103 5090026158 5090020125 5090018430 5090013082 5090012350 5090011630 5090006808 5090011808 5090011504 5090010911 5090010690 5090010117 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5090007672 5090006943 5090020552 5090019945 5090019422 5090035099 5090034711 5090034439 5090033144 5090032908 5090032607 5090031993 5090029206 5090028958 5090026876 5090026590 5090033816 5090033366 5090033175 5090032829 5090032613 5090019495 5090018524 5090018035 5090017671 5090017145 5090016059 5090015604 5090015308 5090014244 5090012061 5090012101 5090011754 5090013291 5090014225 5090013449 5090014000 5090015067 5090010900 5090014512 5090016154 5090012772 5090011076 5090013022 5090011647 5090012812 5090013837 5090013925 5090015172 5090015661 5090015997 Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 0550714031; 0550707898; 0550703257; 0550701001; 0550700271; 0550642393; 0550840775; 0550839511; 0550838865; 0550837444; 0550836705; 0550832513; 0550831053; 0550830130; 0550827079; 0550824869; 0550824214; 0550822892; 0550822106; 0550817357; 0550815598; 0550814986; 0550813249; 0550812388; 0550810967; 0550810105; 0550807402; 0550806425; 0550804679; 0550797903; 0550795059; 0550794450; 0550787218; 0550786385; 0550719996; 0550706561; 0550705373; 0550703839; 0550702722; 0550701675; 0550700484; 0550699347; 0550698067; 0550697346; 0550695879; 0550695123; 0550693506; 0550692919; 0550552609; 0550547819; 0550547323; 0550545129; 0550544636; 0550543696; 0550543036; 0550540333; 0550539557; 0550538346; 0550537062; 550535634; 0550534986; 0550534121; 0550533578; 0550531861; 0550531521; 0550530387; 0550529453; 0550528730; 0550528091; 0550527115; 0550526756; 0550525864; 0550525506; 0550524605; 0550524145; 0550523170; 0550522777; 0550521729; 0550521251; 0550520365; 0550519898; 0550533173; 0550532434; 0550530266; 0550529679; 0550506032; 0550505522; 0550504178; 0550503469; 0550507322; 0550506939; 0550445464; 0550444686; 0550444248; 0550434029; 0550433635; 0550432810; 0550431296; 0550430426; 0550429995; 0550429167; 0550428766; 0550426388; 15178145; 15169617; 15165497; 15156938; 15152640; 15144539; 15140654; 15133243; 15129208; 15121561; 15117328; 15109521; 15094278; 15063410; 15059338; 15052469; 15048936; 15042118; 15038838; 0550489473; 0550489147; 0550488307; 0550487841; 66023104; 66015598; 66009405; 65994399; 65989470; 65984765; 65980682; 65994504; 96392607; 96383278; 96082805; 96075999; 96073186; 96066805; 96063606; 96046753; 96043653; 96036181; 96033203; 96025970; 96023242; 96016510; 96014240; 96006467; 96003060; 81541133; 81535828; 81529087; 81526086; 81518975; 81515837; 81509355; 81505401; 81498512; 81495177; 81488193; 81484850; 81478019; 81474110; 65983928; 66145356; 66138488; 66132752; 66127314; 66120841; 66113683; 66107545; 66097815; 66094616; 66087885; 66060499; 66048053; 66042068; 66033851; 66015185; 66012092; 66002512; 65992234; 0550427911; 0550427551; 0550426756; 0550416062; 0550415387; 0550414959; 0550470797; 0550470388; 0550469601; 0550469209; 0550468486; 0550468132; 0550467340; 0550466893; 0550464927; 0550464554; 0550462268; 0550461089; 0550460274; 0550459858; 0550459107; 0550458038; 0550457599; 0550456813; 0550456363; 0550432456; 96282830; 96281581; 81 FQHNLB; 81 FQHMTJ; 81 FQHMNN; 81 FQHLRQ; 81 FQHLFY; 81 FQMLRR; 81 FQMJNQ; 81 FQMJDH; 81 FQMHQD; 81 FQMHFR; 81 FQMGNN; 81 FQMGCL; 81 FQMFNQ; 81 FQMFDQ; 81 FQMDQG; 81 FQMDHF; 81 FQMCWJ; 81 FQMCPD; 81 FQMBTT; 81 FQMBLX; 81 FQLVRQ; 81 FQLVJM; 81 FQLTYM; 81 FQLTSL; 81 FQLTKV; 81 FQLTFJ; 81 FQLSXM; 81 FQLSSV; 81 FQLSNJ; 81 FQLSFL; 81 FQLRZP; 81 FQLRST; 81 FQLRPH; 81 FQLRHR; 81 FQLRCN; 81 FQLQWL; 81 FQLQSW; 81 FQLQNB; 81 FQLQJW; 81 FQHXBG; 81 FQHWZD; 81 FQHWXV 81 FQHWWJ; 81 FQHWTY; 81 FQHWSM; 81 FQHWQY; 81 FQHWNX; 81 FQHWMP; 81 FQHWKV; 81 FQHWJT; 81 FQHWHB; 81 FQHWFZ; 81 FQHWBW; 81 FQHVRK; 81 FQHTMS; 81 FQHKFK; 81 FQHJTQ; 81 FQHJGJ; 81 FQHHVT; 81 FQHHJS; 81 FQHGYJ; 81 FQHGNW; 81 FQHGDH; 81 FQHFVW; 81 FQHFKJ; 81 FQHFDK; 81 FQGVXD; 81 FQGVSB; 81 FQGVHP; 81 FQGTWS; 81 FQGTNR; 81 FQGTDZ; 81 FQGSVL; 81 FQGSNC; 81 FQGSCY; 81 FQGRRQ; 81 FQGRLS; 81 FQGRBN; 81 FQGQVV; 81 FQGQKY; 81 FQGQFC; 81 FQGPVC; 81 FQGPPD; 81 FQFQFT; 81 FQFPYW; 81 FQFPNJ; 81 FQFPJJ; 81 FQFNXR; 81 FQFNSY; 81 FQFJZV; 81 FQFJWY; 81 FQFJHX; 81 FQFJDC; 81 FQFHSY; 81 FQFHPL; 81 FQFHFF; 81 FQMKTZ; 81 FQMKDS; 81 FQMJRJ; 96323090; 81213351; 20 CDKNHR; 20 CDKQLK; 20 CDKPTV; 20 CDKNZS; 20 CDKNBJ; 20 CDKMSV; 20 CDJVVJ; 20 CDJVNB; 20 CDJVCC; 20 CDJTZB; 20 CDJTNV; 20 CDJTLJ; 20 CDJTBZ; 20 CDJSSH; 20 CDJSMX; 20 CDJRLQ; 66000273; 14912429; 14904967; 14899768; 14881930; 96379899; 96376331; 96368336. Class II Blood products, collected from donors who were previously deferred, were distributed. CSL Plasma, Inc.
Devices Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36775, 36786, 36828, 36864 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36785, 36827 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36829 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36832 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36833 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36850 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36835 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36836 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36781 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36851 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36897 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36815 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Drugs a) Firminite 805 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.FIRMINITE.COM, b) Libidron 410 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.LIBIDRON.COM , c)Extra Strength Instant Hot Rod 496 mg is packaged in 4 count and 10 count capsule blister packs in a box, www.HotRodExtraStrength.com All lots Class I Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs. InSo-Independent Contractor for West Coast Nutritionals,LTD
Drugs Mojo Nights, 1 capsule, UPC 7 18122 11983 7, Distributed By: Mojo Health Lauderhill, FL 33351 All lots, no Expiry Class I Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs. Evol Nutrition
Drugs Mojo Nights for Her, 1 capsule, UPC 7 18122 12133 5, Distributed By: Mojo Health Lauderhill, FL 33351 All lots no Expiry Class I Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs. Evol Nutrition
Biologics Red Blood Cells 11631200368800Q; Class II Blood product, collected from a therapeutic donor with polycythemia vera, was distributed Florida Blood Services, Inc.
Veterinary ZuPreem FruitBlend with Natural Fruit Flavors, Premium Daily Bird Food, for Conures, Amazons, Greys, Pionus, Caiques, Senegals and other medium to large parrots. Packaged in 2 lb, 3.5 lb and 12 lb stand-up plastic pouches; also packaged in 17.5 lb and 35 lb bulk paper bags. Lot 598405052 UPC 762177830209, Exp date: 11/30/2013 (2 lbs package) UPC 762177830308, Exp date: 11/30/2013 (3.5 lbs package) UPC 762177831206, Exp date: 11/30/2013 (12 lbs package) UPC 762177831701, Exp date: 11/13 (17.5 lbs package) UPC 762177833507, Exp date: 11/13 (35 lbs package) Class I The products contain elevated calcium levels. Premium Nutritional Products Inc
Veterinary ZuPreem FruitBlend with Natural Fruit Flavors, Premium Daily Bird Food for Macaws, Cockatoos, Amazons and other Large parrots. Packaged in 2 lb, 3.5 lb and 12 lb stand-up plastic pouches; also packaged in 17.5 lb and 35 lb bulk paper bags. Lot 598405072 UPC 762177840208, Exp date: 11/30/2013 (2 lbs package) UPC 762177840307, Exp date: 11/30/2013 (3.5 lbs package) UPC 762177841205, Exp date: 11/30/2013 (12 lbs package) UPC 76211841700, Exp date: 11/13 (17.5 lbs package) UPC 762177843506, Exp date: 11/13 (35 lbs package) Class I The products contain elevated calcium levels. Premium Nutritional Products Inc
Veterinary Dogsbutter RUC with Flax PB, 16 oz UPC 3050. Best-If-Used-By Dates between March 1, 2011 and September 24, 2013. Class I Sunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. Sunland, Incorporated
Veterinary Sunland Valencia Roasted and Blanched Wildlife, 30 lb UPC 41322. Best-If-Used-By Dates between March 1, 2011 and September 24, 2013. Class I Sunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. Sunland, Incorporated
Veterinary Sunland Raw Shelled Wildlife (not for human use), 50 lb item 402. Identified with Best By Dates March 1, 2011 through September 24, 2013. Class I Sunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. Sunland, Incorporated
Veterinary Dogcandy Holiday Hound Cake 7.5 oz manufactured by Claudia's Canine Cuisine, UPC 692614010041 Best By Date of 08/2015 UPC 692614010041 Class III The product has the potential to contain mold. Claudia's Canine Cuisine
Veterinary Dogcandy Blueberry Hound Cake 7.5 oz manufactured by Claudia's Canine Cuisine , UPC 692614010058 Best By Date of 08/2015 UPC 692614010058 Class III The product has the potential to contain mold. Claudia's Canine Cuisine
Drugs libigrow capsules, PERFORMANCE ENHANCER, supplied in 1, 5 and 10 count blister packs, Distributed By: H & K Nutraceuticals Los Angeles, CA 1 count blister: UPC 094922567611, 5 count blister: UPC 094922567628, 10 count blister: UPC 610585434253. 1 count blister: Lot#: 791115, Exp: 12/13; Lot#: 01M0111, Exp: 01/14; Lot#: 01M0212-1, Exp: 02/15; Lot# 01M0212, Exp: 02/15; Lot# 01M0611-2, Exp: 06/14, 5 count blister: Lot# 05M0412, Exp: 04/16, 10 count blister: Lot# 10M0412, Exp: 04/16. Class I Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs Performance Plus Marketing, Inc.
Drugs libigrow XXXTREME Capsules, MAXIMUM STRENGTH FORMULA, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By Kretek International, Inc. Moorpark, CA 930210 1 count blister: UPC 705105830735, 5 count blister: UPC 610585435939, 10 count blister: UPC 610585435922. 1 count blister: Lot# 01MNU0912, Exp: 09/15; Lot# 01X0412-1, Exp: 04/15; Lot# 021647, Exp: 12/13, 5 count blister: Lot# 05X0412, Exp: 04/16, 10 count blister: Lot# 10X0412, Exp: 04/16; Lot# 10M0111, Exp: 01/14. Class I Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs Performance Plus Marketing, Inc.
Drugs BLUE Diamond Pill, supplied in 1, 5 and 10 count blister packs, Male Sexual Enhancement, Distributed By: DH Distribution Los Angeles, CA 90026. 1 count blister: UPC 705105524764, 5 count blister: UPC 736211124012, 10 count blister: UPC 736211123916. 1 count blister: Lot# 01M0412, Exp: 04/15, and Lot#91782, Exp: 01/14. 5 count blister: Lot# 05M0412, Exp: 04/15; 10 count blister: Lot# 10M0412, Exp: 04/15. Class I Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs Performance Plus Marketing, Inc.
Drugs BLUE Diamond PLATINUM Capsules, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By: DH Distribution Los Angeles, CA 90026 1 count blister UPC -608641933543; 5 count blister UPC - 608641932867; 10 count UPC -608641933536 (1 count)Lot# 01MNU0912, Exp: 08/15, (5 count) Lot# 05BD0712, Exp: 07/15 and 121781, Exp 01/14; (10 count) Lot # 05BD0712, Exp: 07/15 Class I Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs Performance Plus Marketing, Inc.
Drugs Mojo nights Capsules, Male Sexual Enhancer, supplied in 1 and 5 count blister packs, Distributed By: Mojo Health, Pompano Beach, FL I count blister UPC - 718122119738; 5 count blister UPC - 705105836430; (1 count) Lot# 01MJ0712, (1 count) 01MM0211 Exp: 07/15; (5 count) Lot# 05M0912, Exp: 10/15; Class I Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs Performance Plus Marketing, Inc.
Drugs Mojo nights SUPREME Capsules, 1000 mg, Male Sexual Enhancer, supplied in 1 count blister packs, UPC 610585435915; Distributed By: Mojo Health, Pompano Beach, FL Lot# 01MJS0712, Exp 07/15. Class I Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs Performance Plus Marketing, Inc.
Drugs CASANOVA Capsules, 450 mg, MALE SEXUAL ENHANCER, supplied i n1 count blister packs, UPC 736211906892; Distributed by: Casanova Distributors, Tucker, GA Lot# 030112, Exp: 03/15 Class I Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs Performance Plus Marketing, Inc.
Drugs Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension, 1 mL Vials and 2 mL Vials and 1 mL pre-filled syringes, For Office Use Only, Manufactured by Green Valley Drugs, Henderson, NV. Lot #s: 20121105-B, 20121112-G Class I Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV. Green Valley Drugs
Drugs Cyanocobalamin 1000 mcg/ml, injection 30 mL, MDV, For Office Use Only, Green Valley Drugs, Manufactured by Green Valley Drugs, Henderson, NV. Lot: 20121126-H Class I Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV. Green Valley Drugs
Veterinary MoorMan's ShowTec 18 Elite Lamb DC medicated textured grain mix, packaged in 50 lb bags Lot BF23512 - manufactured 08/22/12 184 - 50lb bags produced for sale Lot BF27812 - manufactured 10/04/12 120 - 50lb bags produced for sale Lot BF29312 - manufactured 10/19/12 73 - 50lb bags produced for sale Class I ADM Alliance Nutrition of Bluffton, IN initiated a recall on 12/19/12 for 3 lots of MoorMans® ShowTec 18 Elite Lamb DC sold in 50 lb bags. The recall was initiated in response to a customer complaint stating that 2 of the customers sheep had died of copper toxicosis after consuming MoorMan's® ShowTec 18 Elite Lamb DC. ADM Alliance Nutrition, Inc.
Drugs Super Power capsules, Proprietary Blend 570 mg, packaged in 2-count capsules per blister pack, Distributed by: Freedom Trading, NJ 08863, UPC 7 18122 90678 9. Lot L08108, Exp 06/15 Class I Marketed Without An Approved NDA/ANDA: This dietary supplement has been found to contain sildenafil, an FDA approved drug for the treatment of male erectile dysfunction making this an unapproved new drug. D& S Herbals, LLC
Devices Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate catheter and guidewire insertion. The Proplege coronary sinus catheter provides retrograde cardioplegia during cardiopulmonary by-pass surgery. Model PR9, lot numbers: 59385159, 59385164, 59385204, 59398000, 59398006, 59398008, 59400402, 59423199, 59423200, 59385159, 59385164, 59385204, 59398000, 59398006. Class II Edwards Lifesciences is recalling certain Proplege Coronary Sinus Catheter, model PR9 due to confirmed reports of blood leakage through the hemostasis valve in the introducer that is kitted with the catheter. Edwards Lifesciences, LLC
Drugs Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, UPC 3 61958 01011 5; NDC 61958-0101-1. Lot #: B120217A, Exp 05/15 - US Distribution Class I Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection). Gilead Sciences, Inc.
Biologics Source Plasma UQ170193; UQ169364; UQ167981; UQ167387; Class II Blood products, collected from a donor who was previously deferred, were distributed. Plasma Biological Services Inc
Biologics Platelets Pheresis Leukocytes Reduced W120612021337 Part A; W120612021337 Part B Class II Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed. Michigan Blood
Biologics Platelets Pheresis Leukocytes Reduced W051512134136; Class II Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. Memorial Blood Centers
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W051512077416; W051512077426; W051512077431; Class III Blood products, labeled with incorrect volume, were distributed. Memorial Blood Centers
Biologics Red Blood Cells Leukocytes Reduced Irradiated 1413206; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Memorial Blood Centers
Biologics Blood and Blood Products for Reprocessing 1413206; Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Memorial Blood Centers
Biologics Plasma Frozen within 24 hours (FP24) 009KE30955; Class II Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced W038112201491; Class II Blood products, collected from a donor who was previously deferred, were distributed. Florida's Blood Centers, Inc.
Biologics Plasma Frozen W038112201491; Class II Blood products, collected from a donor who was previously deferred, were distributed. Florida's Blood Centers, Inc.
Biologics Source Plasma 0050349533; 0050350236; Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. Biomat USA, Inc
Veterinary Nature's Variety Instinct raw, Organic Chicken Formula medallions, packaged in 3-lb bags and packaged 9/3-lb bags/case. UPC # 7 69949 60137 1, 3-lb bag Best if Used By date of 10/04/13 UPC # 7 69949 70137 8, 27-lb case (9/3-lb bags/case) Best if Used By date of 10/04/13 Class I The products may contain hard plastic pieces. MI Industries Inc
Veterinary Nature's Variety Instinct raw, Organic Chicken Formula patties, packaged in 6-lb bags and packaged in 6/6-lb bag/cases. UPC # 7 69949 60127 2, 6-lb bag Best if Used By date of 10/04/13 UPC # 7 69949 70127 9, 36-lb case (6/6-lb bags/case) Best if Used By date of 10/04/13 Class I The products may contain hard plastic pieces. MI Industries Inc
Biologics Red Blood Cells Leukocytes Reduced W230811203265; Class II Blood products, which were not quarantined subsequent to receiving information regarding donor's deferral status, were distributed. Coastal Bend Blood Center
Biologics Blood and Blood Products for Reprocessing W230811203265; Class II Blood products, which were not quarantined subsequent to receiving information regarding donor's deferral status, were distributed. Coastal Bend Blood Center
Devices REF 1103***HVAD Pump Implant Kit. Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Serial Numbers: United States: HW001-HW3827 and International: HW001-HW3827 and HW1000-HW10675 Class II HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector. Heartware Inc
Biologics Bone 0092190096 Class II Human tissue allograft was processed in a manner that could cause contamination or cross-contamination during processing, and well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P. University Of Miami Miller School of Medicine Tissue Bank
Devices QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time PCR assay. One service package containing the handbook. Catalog Number 4503225, Lot #142345648, Exp: 06/09/14 & Lot #142357718 Exp: 06/09/14 Class II CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials. QIAGEN Gaithersburg, Inc.
Devices QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR ASR is designed to detect and to quantify nucleic acid specific to human cytomegalovirus (CMV) using real-time PCR technology (PCR) in the Rotor-Gene 2000/3000 (RG). Catalog Number 4503223, Lot #142345647, Exp: 06/09/14 Class II CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials. QIAGEN Gaithersburg, Inc.
Food Adobo sin pimienta (Adobo without pepper) in 5 oz, 14 oz, and 32 oz No code dates. Firm recalling all product purchased between 3/1/2011 to 3/27/2013 Class I Undeclared allergen - Soy Lisy Corp.
Food Adobo con pimienta (Adobo with pepper) in 5 oz, 14 oz, and 32 oz No code dates. Firm recalling all product purchased between 3/1/2011 to 3/27/2013 Class I Undeclared allergen - Soy Lisy Corp.
Food Sazonador de Carnes (Meat Seasoning) in 5 oz, 14 oz, and 28 oz No code dates. Firm recalling all product purchased between 3/1/2011 to 3/27/2013 Class I Undeclared allergen - Soy Lisy Corp.
Food Sazon Perfecta (Perfect Seasoning) in 4 oz, 12 oz, and 24 oz No code dates. Firm recalling all product purchased between 3/1/2011 to 3/27/2013 Class I Undeclared allergen - Soy Lisy Corp.
Food Sazon Fajita (Fajita Seasoning) in 5 oz, 14 oz, and 28 oz No code dates. Firm recalling all product purchased between 3/1/2011 to 3/27/2013 Class I Undeclared allergen - Soy Lisy Corp.
Food Heartland Gourmet Gluten Free double chocolate cookie mix, DAIRY FREE, packaged in 16-oz. boxes. Manufactured by: Heartland Gourmet, LLC, Lincoln, NE. Lots 0022317 best buy date 10/2014, 012341 best buy date 01/2014, and 0012289 best buy date 10/2014 Class I Some of the products contain milk but are labeled as dairy free. Heartland Gourmet, LLC
Food Heartland Gourmet Gluten Free chocolate chip cookie mix, DAIRY FREE, packaged in 16-oz. boxes. Manufactured by: Heartland Gourmet, LLC, Lincoln, NE. Lot 023065, best buy date 12/2014 and Lot 0023007, best buy date 10/2014. Class I Some of the products contain milk but are labeled as dairy free. Heartland Gourmet, LLC
Food Heartland Gourmet Gluten Free rosemary basil pizza crust mix, DAIRY FREE, packaged in 15.4-oz. boxes. Manufactured by: Heartland Gourmet, LLC, Lincoln, NE. Lot 073007 best buy date 09/2014 Class I Some of the products contain milk but are labeled as dairy free. Heartland Gourmet, LLC
Drugs Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative Free, Compounded by NuVision Pharmacy, Inc., Dallas, TX 75244 Lot Number N01232013@4, Do Not Use Beyond Date of January 1, 2014 Class II Lack of Assurance of Sterility; reports of adverse events after injection NuVision Pharmacy, Inc.
Devices Dural Graft Matrix DuraGen® Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.. 1125807, 1125802, 1125806, 1125804, 1125808, 1111845, 1125805, 1125803, 1125809, 1125810, 1130069, 1130061, 1130064, 1130065, 1130417, 1130521, 1110850, 1111839, 1111621, 1110274, 1105302, 1110669, 1111618, 1112228, 1110160, 1110670, 1111606, 1111616, 1104916, 1111614, 1111615, 1110273, 1111277, 1111849, 1110667, 1104918, 1110853, 1111619, 1111842, 1110666, 1112109, 1112108, 1104917, 1110854, 1111620, 1110276, 1105301, 1111846, 1112225, 1110851, 1111617, 1105303, 1110852, 1110270, 1105304, 1110246, 1112222, 1112224, 1110245, 1111844, 1111850, 1110668, 1125522, 1125628, 1104879, 1110814, 1111610, 1125525, 1104876, 1110815, 1111607, 1125526 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component. Suturable DuraGen is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes. Suturable DuraGen may be applied using either on-lay or suturing techniques depending on clinical need and surgeon preference. 1125682, 1125681 1125817, 1125983, 1126018 1126019, 1130641 1130642, 1110848, 1110849 1111883, 1111354, 1111884 1111936, 1112151 1110256, 1111355 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes. 1125523, 1125517 1125522, 1125539 1125524, 1125525 1125526, 1125632 1125630, 1125678 1125679 1125677, 1125683 1125628, 1125813 1125814, 1125815 1125629, 1125520 1125521, 1125979 1126031, 1125980 1125981, 1125982 1126030, 1130243 1130071, 1130503 1130379, 1130381 1130384, 1130507 1130374, 1130380 1130382, 1130421 1130505, 1130424 1130654, 1130422 1130423, 1130428 1130639, 1130413 1130414, 1130383 1130425, 1130504 1130506, 1130426 1130427, 1130970 1130827, 1111606 1104879, 1110814 1111610, 1104876 1110815, 1111607 1110268, 1111360 1112339, 1104405 1104877, 1105455 1112008, 1112110 1112111, 1110845 1111940, 1112149 1104880, 1112148 1110244, 1110265 1110846, 1104878 1111609, 1111941 1104881, 1110812, 1110267, 1111359, 1112340, 1105307, 1111611, 1111939, 1112341, 1110266 1112146, 1112147 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, porous collagen matrix. DuraGen XS is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes. 1125963, 1130387 1130386, 1130468 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue. 1112107 1111938, 1112280, 1112038, 1111971 1112279, 1112104, 1112105 1112297, Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. 1105457 1112377, 1112378 1112103 1112106, 1112003, 1112296, 1110715 1112052, 1112004, 1112030 1111972 1112376 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or impractical. 1105177, 1105178 1110143, 1110227 1110228, 1110229 1110230, 1110233 1110786, 1110787 1111356, 1105179 111023 1, 1110232 1110785 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. 1104789 1104790, 1110793 1112248, 1110248 1111867 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. 1110788, 1112217 1110222, 1111357 1111602, 1105255 1110224, 1110225 1111601, 1110223 1110790, 1111603 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes. 1125130 ,1125686 1125687, 1125688 1126015, 1105298 1110145, 1110674 1111854, 1104502 1104503, 1105309 1105310, 1110249 1111366, 1111367 1111368, 1111370 1112262 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes. 1125684, 1125685 1125689, 1126014 1104963, 1110481 1110791, 1110792 1111363, 1111644 1110673, 1111856 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes. 1104500, 1104623 1105315, 1105316 1105317, 1110234 1110235, 1110236 1110237, 1110238 1110239, 1110240 1110784, 1111151 1111152, 1111153 1111155, 1111156 1111157, 1111646 1105300 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes. 1125414, 1126013 1130645, 1110250 1110251, 1110252 1111365, 1111878 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes. 1104622, 1104962 1110241, 1110242 1110264, 1110783 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes. 1126012, 1105396 1105397, 1105398 1105399, 1111364 1111641 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes. 1110144, 1110243 1110782, 1111645 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices OraMem Absorbable Collagen Membrane OraMem® Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus. 1112066 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices BioMend® Extend" Absorbable Collagen Membrane BioMend® Extend" Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus. 1104846, 1105175 1105253, 1110810 1110811, 1111149 1111859, 1104847 1105176, 1105254 1110809, 1111860 1104848, 1110819 1110820, 1111148 1111861 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of peridural fibrosis. 1125812 1125816 1126021 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices BioMend Absorbable Collagen Membrane BioMend® Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus. 1105251, 1105462, 1110805, 1110806, 1111144, 1110480, 1111145, 1111358, 1105392, 1110142, 1110807, 1111146, 1111362, 1111640, 1105252, 1105463, 1110808, 1111147, 1111865, 1110671, 1110672, 1111958, 1105393, 1111959, 1105394, 1110480, 1112022, 1105391 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices Absorbable Collagen Sponge Provided As Intermediate to Another Company 1130055, 1130057, 1130228, 1130229, 1130388, 1105192, 1110821, 1110822, 1110987, 1111023, 1112020, 1112379, 1104815, 1110841, 1110842, 1110843, 1110953, 1110954, 1111022, 1111821, 1105206, 1110844, 1110903, 1110904, 1110931, 1110932, 1112021, 1104791, 1104961, 1105174, 1105453, 1105454, 1110826, 1110827, 1110969, 1111159, 1111160, 1104710, 1110828, 1111158, 1111764 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine, Part No. 604018 - Lot No. 6821, 6822, 6823, 6824, 6825, 6831, 6832, 6841, 6851, 6852, 6853, 6861, 6862, 6863, 6864, 6865, 6866, 6867, 6868, 6871, 6881, 6891, 6892, 6901, 6902, 6903, 6904, 6911, 6912, 6921, 6922, 6931, 6942; Part No. 604019 - Lot No. 6321, 6331, 6341, 6351; Part No. 604020 - Lot No. 6361, 6371; Part No. 604022 - Lot No. 6551, 6552, 6561, 6562, 6563, 6564, 6571, 6581, 6582, 6583, 6584, 6591, 6592, 6593, 6601, 6602, 6603, 6611, 6612, 6621, 6622, 6623, 6631, 6632, 6641, 6651, 6652, 6661, 6671, 6672, 6681; Part No. 604026 - Lot No. 6041, 6051; Part No. 604028 - Lot No. 6051, 6061, 6071, 6081, 6091, Class II Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory testing. Medtox Diagnostics Inc
Food Centerville Pie Company Clam Pie, 2 lb (Large) and 1 lb (Small) All codes Class I Undeclared allergen-anchovies Centerville Pie Company, Inc.
Drugs ROCK-IT MAN capsules, male sexual stimulant, packaged in 1-count (UPC 8 53447 02003 8) and 2-count (UPC 8 53447 00204 1) blister cards, Distributed by Consumer Concepts. All product sold between 01/01/13 through 03/27/13. Class I Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomosildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug. Consumer Concepts, Inc.
Drugs BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30 mg), 1 Fl. Oz. (30 mL), Manufactured for GIL PHARMACEUTICAL CORP, PONCE, PUERTO RICO 00717-1565 -- NDC 58552-103-01 Lot 611614 (exp. 09/2013) Class III Subpotent; Cetylpyridinum Chloride Hi-Tech Pharmacal Co., Inc.
Food Add a Scoop by Smoothie Essentials; Probiotic; Supports Digestive Health, dietary supplement; Net Weight: 1 lb (464g) 16 oz. Contains Bacillus Coagulans GBI-30-6086 in a base of Maltdextrin. Gluten Free, GMO Free Manufactured for: Juice Bar Solutions, 38 Maybeck St., Novato, Ca 94949. Product of USA Lot # 120615, Best by 8/2014; UPC 6 88683 10800 0 Class III It was discovered that label for Add a Scoop Probiotic stated that it was GMO free, however manufacturers paperwork did not support the claim. Juice Bar Solutions
Devices AMS 800® Urinary Control System. The AMS 800® Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800® Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck. 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72400098 790170012 72400098 790170013 72400098 790170014 72400098 790170015 Class II American Medical Systems, Inc. is initiating a recall on two components of the AMS 800® Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria. American Medical Systems, Inc.
Devices AMS 800® Urinary Control System. The AMS 800® Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800® Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck. Model # Lot # 72400024 771029003 72400024 794405011 72400024 744211005 72400024 794405007 72400024 744211008 72400024 771029001 72400024 794405006 72400024 771029005 72400024 744211009 72400024 771029016 72400023 741419006 72400024 794405001 72400024 794405002 72400024 794405004 72400024 794405005 72400024 794405015 72400024 794405016 72400024 744211001 72400024 744211004 72400024 800345007 72400024 800345014 72400024 771029012 72400024 794405009 72400024 794405012 72400024 794405013 72400024 794405014 72400023 741419004 72400023 741419005 72400023 741419007 72400023 741419009 72400023 741419010 72400024 744211002 72400024 744211003 72400024 744211006 72400024 744211007 72400024 744211010 72400024 744211011 72400024 771029002 72400024 771029004 72400024 771029006 72400024 771029007 72400024 771029008 72400024 771029009 72400024 771029010 72400024 771029011 72400025 803589003 72400024 771029014 72400024 771029015 72400025 803589005 72400024 794405003 72400024 771029013 72400024 794405008 72400024 800345008 72400024 794405010 72400024 800345001 72400024 800345003 72400024 800345004 72400024 800345005 72400024 800345006 72400024 800345009 72400024 800345010 72400024 800345012 72400024 800345015 72400024 800345002 Class II American Medical Systems, Inc. is initiating a recall on two components of the AMS 800® Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria. American Medical Systems, Inc.
Drugs Acetylcysteine Injection, all strengths and all presentations including 100 mg/mL in 30 mL vials and 200 mg/mL in 30 mL and 50 mL vials, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130129-J, 20130129-L, Exp 04/29/13; 20130405-H, Exp 07/05/13. Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Alpha Lipoic Acid Injection, all strengths and all presentations including 25 mg/mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130319-C, Exp 06/19/13; 20130329-C, Exp 06/29/13 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Amikacin Injection, all strengths and all presentations including 50, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130116-A, Exp 04/16/13 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Ascorbic Acid Injection, all strengths and all presentations including a) 500 mg/mL, b) corn source 500 mg/mL, c) tapioca 500 mg/mL, d) cassave 500; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) 20130313-M, Exp 6/13/2013; 20130306-N, Exp 6/6/2013; 20130220-E, Exp 5/20/2013; 20130222-D, Exp 5/22/2013; 20130205-B, Exp 5/5/2013; 20130205-C, Exp 5/5/2013; 20130222-F, Exp 5/22/2013; 20130315-H, Exp 6/15/2013; 20130313-L, Exp 6/16/2013; 20130306-O, Exp 6/6/2013; 20130328-A, Exp 6/28/2013; 20130404-F, Exp 7/4/2013; 20130333-B, Exp 6/30/2013; 20130301-D, Exp 6/1/2013; 20130311-H, Exp 6/11/2013; 20130328-A, Exp 6/28/2013; 20130404-D, Exp 7/4/2013; 20130404-E, Exp 7/4/2013; 20130315-G, Exp 6/15/2013; 20130322-G, Exp 6/22/2013; 20130228-D, Exp 5/28/2013; 20130205-B, Exp 5/5/2013; b) 20130315-G, Exp 6/15/2013; 20130322-G, Exp 6/22/2013; c) 1302121000AE, Exp 5/12/2013; 20130322-C, Exp 6/22/2013; 20130401-C, Exp 7/1/2013; 20130131-D, Exp 4/30/2013; 20130213-A, Exp 5/13/2013; 20130305-G, Exp 6/5/2013; 20130131-B, Exp 4/30/2013; 20130201-D, Exp 5/1/2013; 2013201-G, Exp 5/1/2013; 20130222-E, Exp 5/22/2013; 20130322-B, Exp 6/22/2013; 20130131-C, Exp 4/30/2013; 20130131-E, Exp 4/30/2013; 20130213-A, 5/13/2013; 20130201-A, Exp 5/2/2013; 20130221-T, Exp 5/21/2013; 20130311-D, Exp 6/11/2013; 20130311-C, Exp 6/11/2013; 20130311-B, Exp 6/11/2013; 20130314-A, Exp 6/14/2013; 20130314-B, Exp 6/14/2013; 20130315-D, Exp 6/15/2013; 20130304-A, Exp 6/4/2013; 20130318-L, Exp 6/18/2013; 20130325-B, Exp 6/25/2013; 20130318-M, Exp 6/18/2013; d) 20130128-C, Exp 4/28/2013; 20130124J, Exp 4/24/2013; 20130403-C, Exp 7/3/2013; 20130124-J, Exp 4/24/2013, 20130115-I, Exp 4/15/2013. Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Betamethasone Acetate and Betamethasone Sodium Injection, all strengths and all presentations including 6 mg/mL preservative free, 2 ml; 106 mg/mL 10 mL, and 6 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130114-A, Exp 4/14/2013; 20130123-B, Exp 4/23/2013; 20130124-A, Exp 4/24/2013; 20130212-A, Exp 5/12/2013; 20130321-B, Exp 6/21/2013; 20130319-M, Exp 6/19/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Bacteriostatic Water for Injection, all presentations including 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130122-C, Exp 4/22/2013; 20130122-D, Exp 4/22/2013; 20130319-A, Exp 6/19/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs B-Complex Injection, all strengths and all presentations including a) B-Complex Injection 30 mL; b) B-Complex PF 2 mL; c) B-Complex Plus-100; d) B-Complex_B12_30 mL; e) B-Complex-50-Methyl-30-Lido 30 mL; f) B-CompSuper-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) B-Complex: 20130228-B, Exp 5/28/2013; 20130125-B, Exp 4/25/2013; b) B-Complex PF 2ml: 20130219-D, Exp 5/19/2013; 20130319 -J, Exp 6/19/2013; c) B-Complex Plus-100: 20130307-D, Exp 6/7/2013; 20130123-E, Exp 4/23/2013; d) B-Complex_B12_30ml: 20130212-F, Exp 5/12/2013; e) B-Complex-50-Methyl-30-Lido 30ml: 20130206-M, Exp 5/6/2013; f) B-CompSuper-30ml: 1302042000AE, Exp 5/4/2013. Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Betamethasone Combination Injection, all strengths and all presentations including a) Beta combo 6 mg/mL, 3 mL, b) Betameth_Combo_PF-6-2 Syr, and c) Betamethasone Combo 6 mg/mL Syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Beta combo: 20130123-B, Exp 4/23/201, b) Betameth_Combo_PF-6-2 Syr: 13031230GV1, Exp 6/12/2013; 13032060GV2, Exp 6/20/2013; 13011650GV7, Exp 4/16/2013; 13012330GV1, Exp 4/23/2013; 13020525Gv1, Exp 5/5/2013; c) Betamethasone Combo 6mg/ml Syr: 20130304-GV2, Exp 5/4/2013; 13031230GV1, Exp 6/12/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs BET-ACE-LIDO-6-2 Injection, all strengths and all presentations including 7 mL syringe and Betameth Combo 6 mg/mL Lidocaine 2% Syringe, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 13012320-GV1, Exp 4/23/2013; 13021840GV1, Exp 5/18/2013; 13031150GV1, Exp 6/11/2013; 13021840GV1, Exp 5/18/2013; 13012320-GV1, Exp 4/23/2013; 13011532, Exp 4/15/2013. Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Betamethasone Sodium Phosphate Injection, all strengths and all presentations including 6 mg/2 mL PF and 6 mg/mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130405-F, Exp 7/5/2013; 20130222-A, Exp 5/22/2013; 20130405-F, Exp 7/5/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Betamethasone Combination with Lidocaine 1% and Bupivacaine 0.5 % Injection, all strengths and all presentations including a) Betameth combo 6 mg/mL lido 1% bup 0.5% syr; and b) Betameth Combo/Lidocaine 1%/ Bupivacaine 0.5% Syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Betameth combo 6mg/ml lido1% bup 0.5% syr: 13021975, Exp 5/19/2013; b) Betameth Combo/Lidocaine 1%/ Bupivacaine 0.5% Syr: 13012550, Exp 4/25/2013; 130215100, Exp 5/15/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Biotin Injection, all strengths and all presentations including Biotin-15-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 130117500AE, Exp 4/17/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Bupivacaine and Dexamethasone Injection, all strengths and all presentations including Bupiv_Dexameth-0.25-10.5; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 13011450GV4, 13011450GV1, Exp 4/14/2013; 13011760B, Exp 4/17/2013; 13012450, Exp 4/24/2013; 13021960GV2, Exp 5/19/2013; 2013021950GV2, Exp 5/19/2013; 20130222GV3, Exp 5/22/2013; 13020450GV3, Exp 5/4/2013; 13020850GV2, Exp 5/8/2013; 13031330GV2, Exp 6/13/2013; 13032730GV1, Exp 6/27/2013; 20130327GV2, Exp 6/27/2013; 1303031475GV2, Exp 6/3/2013; 130301100GV2, Exp 6/1/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Bupivacaine Injection, all strengths and all presentations including a) Bupivacaine Parabens Free 0.5% 50 mL, and b) Bupivacaine PF 0.5% 30 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Bupivacaine PF 0.5% 30 mL SDV: 20130318-C, Exp 6/18/2013; 20130319-F, Exp 6/19/2013; b) Bupivacaine Paraben Free 0.5% 50 mL: 20130212-E, Exp 5/12/2013; 20130124-F, Exp 4/24/2013; 20130214-G, Exp 5/14/2013; 20130320-E, Exp 6/20/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Buprenorphine Injection, all strengths and all presentations including Buprenorphine-0.3 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 130129300AEB, Exp 4/29/2013. Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Vitamin D3 Injection, all strengths and all presentations including a) Cholecalciferol D3 50,000iu 30 mL, b) Calcitriol D3 10,000iu, and c) Calcitriol D3 50,000iu, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130130-A, Exp 4/30/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Cyanocobalamin Injection, all strengths and all presentations including a) Cyanocobalamin 1000mcg, b) Cyanocobalamin 1000 mcg/mL in 1 mL, 10 mL, and 30 mL and 1 mL Preservative Free, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Cyanocobalamin 1000mcg: 20130214-C, Exp 5/14/2013; 20130220-B, Exp 5/20/2013; 20130226-D, Exp 5/26/2013; 20130226-E, Exp 5/26/2013; 20130226-L, Exp 5/26/2013; 20130125-E, Exp 4/25/2013; 20130125-D, Exp 4/25/2013; 20130125-C, Exp 4/25/2013; 20130125-F, Exp 4/25/2013; 20130211-M, Exp 5/11/2013; 20130214-B, Exp 5/14/2013; 20130221-D, Exp 5/21/2013; 20130225-K, Exp 5/25/2013; 20130214-B, Exp 5/14/2013; 20130226-C, Exp 5/26/2013; 20130226-I, Exp 5/26/2013; 20130225-M, Exp 5/25/2013; 20130225-N, Exp 5/25/2013; 20130225-J, Exp 5/25/2013; 20130225-C, Exp 5/25/2013; 20130204-G, Exp 5/4/2013; 20130204-F, Exp 5/4/2013; b) Cyanocobalamin 1000mcg 30ml: 20130325-D, Exp 6/25/2013; 20130325-C, Exp 6/25/2013; 20130326-E, Exp 6/26/2013; 20130326-I, Exp 6/26/2013; 20130329-L, Exp 6/29/2013; 20130329-M, Exp 6/29/2013; 20130306-Q, Exp 6/6/2013; 20130308-K, Exp 6/8/2013; 20130401-O, Exp 7/1/2013; 20130401-M, Exp 7/1/2013; 20130402-C, Exp 7/2/2013; 20130402-B, Exp 7/2/2013; 20130329-K, Exp 6/29/2013; 20130308-L, Exp 6/8/2013; 20130401-N, Exp 7/1/2013; 20130402-H, Exp 7/2/2013; 20130402-D, Exp 7/2/2013; 20130402-A, Exp 7/2/2013; 20130403-A, Exp 7/3/2013; 20130318-P, Exp 6/18/2013; 20130318-O, Exp 6/18/2013; 20130318-Q, Exp 6/18/2013; 20130319-B, Exp 6/19/2013; 20130226-B, Exp 5/26/2013; 20130318-A, Exp 6/18/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Cyclosporine Injection, all strengths and all presentations including Cyclosporine 2% Aqueous Solution 15 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130122-F, Exp 4/22/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Dexamethasone Sodium Phosphate Injection, all strengths and all presentations including a) Dexamethasone Sodium Phosphate 10 mg/1 mL, b) Dexamethasone Sodium Phosphate 10 mg/mL PF 1 mL, c) Dexamethasone Sodium Phosphate 4 mg/30 mL, d) Dexamethasone-4 mg/5 mL P.F., Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Dexamethasone Sodium Phosphate 10mg/1ml: 20130402-F, Exp 7/2/2013; b) Dexamethasone Sodium Phosphate 10mg/ml PF 1ml: 20130307-H, Exp 6/7/2013; c) Dexamethasone Sodium Phosphate 4mg/30ml: 20130117-B, Exp 4/17/2013; 20130326-C, Exp 6/26/2013; 20130307-E, Exp 6/7/2013; 20130221-D, Exp 5/21/2013; d) Dexamethasone-4mg/5ml P.F.: 20130328-L, Exp 6/28/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Dexpanthenol Injection, all strengths and all presentations including Dexpanthenol 250 mg/30 mL; Dexpanthenol 250 mg/mL 10 mL, 30 mL, 50 mL; and Dexpanthenol 250 mg/mL 10 mL P.F.; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130212-A, Exp 5/12/2013; 20130122-E, Exp 4/22/2013; 20130212-D, Exp 5/12/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Dimercapto-propane-sulfonic acid (DMPS) Injection, all strengths and all presentations including a) DMPS 50 mg/5 mL, b) DMPS 50 mg/mL PF 5 mL, c) DMPS Acid 250 mg/5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) DMPS 50 mg/5 mL: 20130326-F, Exp 6/26/2013; b) DMPS 50 mg/mL PF 5 mL: 20130311-A, Exp 6/11/2013; c) DMPS Acid 250 mg/5 mL: 20130130-K, Exp 4/30/2013; 20130212-C, Exp 5/12/2013; 20130311-A, Exp 6/11/2013; 20130308-M, Exp 6/8/2013; 20130130-E, Exp 4/30/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Dimethyl Sulfoxide (DMSO) Injection, all strengths and all presentations including DMSO 99% 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130130-L, Exp 4/30/2013; 20130306-G, Exp 6/6/2013; 20130131-L, Exp 4/30/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Edetate Disodium Injection, all strengths and all presentations including a) Edetate Disodium 150/30 mL and b) Edetate Disodium 150/100 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Edetate Disodium_150/30 mL: 20130201-E, Exp 5/2/2013; b) Edetate Disodium_150/100 mL: 20130124-B, 4/24/2013; 20130213-B, Exp 5/13/2013; 20130213-C, Exp 5/13/2013; 20130401-B, Exp 7/1/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Edetate Calcium Disodium Injection, all strengths and all presentations including a) Edetate Calcium Disodium 300 mg/mL 100 mL, b) Edetate Calcium Disodium 300-30 mL, c) Calcium Edetate 200 mg/mL 15 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Edatate Calcium Disodium 300 mg/mL 100mL: 20130319-H, Exp 6/19/2013; 2010318-N, Exp 6/18/2013; b) Edetate Calcium Disodium 300-30 mL: 20130205-H, Exp 5/5/2013; 20130318-N, Exp 6/18/2013; 20130319-H, Exp 6/19/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs ED Mix Injections, all strengths and all presentations including a) ED mix TM -at 2, b) ED-Mix BI-Mix 10 30 mL, c) ED-Mix BI-Mix 9 30 mL; d) ED-Mix BI-Mix-3-30, e) ED-Mix PGE 80-30, f) ED-Mix SB4 30 mL, g) Ed-Mix ST 9E, h) ED-Mix ST-1, i) ED-MIX T106, j) ED-MIX-PGE-150 30 mL, k) ED-MIX-PGE-40-30, l) ED-MIX-ST 9A, m) ED-MIX-ST 9D, n) ED-MIX-ST-9B, o) ED-MIX-T 101, p) ED-MIX-T105, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) ED mix TM -at 2: 20130306-M, Exp 6/6/2013; b) ED-Mix BI-Mix 10 30 mL: 130207120AE, Exp 5/7/2013; c) ED-Mix BI-Mix 9 30 mL: 20130121-G, Exp 4/21/2013; 20130301-F, Exp 5/1/2013; d) ED-Mix BI-Mix-3-30: 20130124-H, Exp 4/24/2013; 20130305-J, Exp 6/5/2013; e) ED-Mix PGE 80-30: 1302041000AE, Exp 5/4/2013; 20130313-B, Exp 6/13/2013; 20130322-H, Exp 6/22/2013; 20130405-I, Exp 7/5/2013; f) ED-Mix SB4 30 mL: 130304150AE, Exp 6/4/2013; g) Ed-Mix ST 9E: 2013220-C, Exp 5/20/2013; h) ED-Mix ST-1: 20130313-A, Exp 6/13/2013; 20130322-l, Exp 6/22/2013; 20120220-H, Exp 5/20/2013; 20130208-I, Exp 5/8/2013; i) ED-MIX T106: 20130322-M, Exp 6/22/2013; 20130204-L, Exp 5/4/2013; 20130313-D, Exp 6/13/2013; 20130306-R, Exp 6/6/2013; 20130401-H, Exp 7/1/2013; j) ED-MIX-PGE-150 30 mL: 20130401-J, Exp 7/1/2013; k) ED-MIX-PGE-40-30: 20130307-B, Exp 6/7/2013; 20130322-I, Exp 6/22/2013; l) ED-MIX-ST 9A: 20130401-K, Exp 7/1/2013; m) ED-MIX-ST 9D: 20130401-L, Exp 7/1/2013; n) ED-MIX-ST-9B: 20130327-A, Exp 6/27/2013; o) ED-MIX-T 101: 20130322-J, Exp 6/22/2013; 20130220-D, Exp 5/20/2013; p) ED-MIX-T105: 20130322-K, Exp 6/22/2013; 20130204-K, Exp 5/4/2013; 20130220-F, Exp 5/20/2013; 20130401-I, Exp 7/1/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Estradiol Cypionate Injection, all strengths and all presentations including a) Estradiol Cypionate 5 mg/mL 10 mL and b) Estradiol Cypionate 10 mg/mL 10 ml, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130226-F, Exp 5/26/2013; 20130117-K, Exp 4/17/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Estradiol Valerate Injection, all strengths and all presentations including a) Estradiol Valerate 40-10 mL and b) Estradiol Valerate 40-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130114-B, Exp 4/14/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Folic Acid Injection, all strengths and all presentations including a) Folic Acid 10 mg/mL 30 mL; b) Folic Acid PF 10 mg/mL 2 mL and 5 mL; c) Folic Acid 20 mg/mL 30 mL; d) Folic Acid 5 mg/mL 5 mL, 10 ml and 30 mL Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Folic Acid 10 mg/30 mL: 20130204-D, Exp 5/4/2013; b) Folic Acid PF 10mg/mL 2 mL: 20130219-E, Exp 5/15/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Furosemide Injection, all strengths and all presentations including a) Furosemide PF-10 mg-10 mL, b) Furosemide PF-10 mg-2 mL SDV, and Furosemide 10 mg/mL 4 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Furosemide PF-10 mg-10 mL: 20130201-F, Exp 5/1/2013; b) Furosemide PF-10 mg-2 mL SDV: 20130306-F, Exp 6/6/2013. Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Gentamicin Injection, all strengths and all presentations including a) Gentamicin 40 mg/2 mL, b) Gentamicin 40 mg/30 mL, c) Gentamicin-40-20 mL, d) Gentamicin-40 mg/mL-2 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Gentamicin 40 mg/2 mL: 20130403-D, Exp 7/3/2013; 20130227-H, Exp 5/27/2013; b) Gentamicin 40 mg/30 mL: 20130204-E, Exp 5/4/2013; c) Gentamicin-40-20 mL: 20130204-E, Exp 5/4/2013; d) Gentamicin-40 mg/mL-2 mL; 20130227-A, Exp 5/27/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Glycerin/Lidocaine/Epinephrine Injection including Glycerin 72% Lido:Epi 2-1-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130211-U, Exp 5/11/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Human Chorionic Gonadotropin Injection, all strengths and all presentations including a) HCG 1000u/mL, b) HCG 1000u/mL 10mL, c) HCG 1000u Folic 400 mcg Methyl 5 mg 10 mL, d) HCG Kit 1 Day w/ Drug; HCT 750u/0.75 mL Pre-Filled Syringe, e) HCG Syringe 150iu/0.15 mL, f) HCG 1500u/1.5 mL Pre-Filled Syringe, g) HCG 5000 unit/5 mL vial, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) HCG 1000u/mL: 20130319-E, Exp 5/19/2013; b) HCG 1000u/mL 10mL: 20130221-J, Exp 4/21/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Hyaluronidase Injection, all strengths and all presentations including a) Hyaluronidase 150u/mL, b) Hyaluronidase 150u/ml 1 mL PF, c) Hyaluronidase 150u/mL PF 1ml SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Hyaluronidaise 150u/mL: 20130205-G, Exp 5/5/2013; b) Hyaluronidase 150u/mL 1 mL PF: 20130321-A, Exp 6/21/2013; c) Hyaluronidase 150u/mL PF 1ml SDV: 20130313-E, Exp 6/13/2013. . Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Hydrochloric Acid Injection, all strengths and all presentations including a) Hydrochloric Acid 0.6%, b) Hydrochloric Acid 2%, c) Hydrochloric Acid Injection 0.06% 30 mL, d) Hydrochloric Acid 2 mg/mL Injection 30 mL vial, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Hydrochloric Acid 0.6%: 20130212-H, Exp 5/12/2013; b) Hydrochloric Acid 2%: 2013012952000AE, Exp 4/29/2013 . Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Hydrogen Peroxide Injection, all strengths and all presentations including Hydrogen Peroxide 3% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130225-H, Exp 5/25/2013; 20130130-I, Exp 4/30/2013; 20130311-I, Exp 6/11/2013. Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Hydroxocobalamin Injection, all strengths and all presentations including a) Hydroxocobalamin 1000 mcg/mL 30mL and b) Hydroxocobalamin 1000 mcg/mL 10 mL P.F., Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Hydroxocobalamin 1000 mcg/mL 30 mL: 20130321-C, Exp 6/21/2013; 20130404-H, Exp 7/3/2013; 20130225-H, Exp 5/25/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Hydroxyprogesterone Caproate Injection, all strengths and all presentations including Hydroxyprogesterone Caproate 250 mg/mL 1 mL, 4 mL, 5 mL, 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: Hydroxyprogesterone Caproate 250 mg/mL 4 mL: 20130204-A, Exp 5/4/2013; 20130117-G, Exp 4/17/2013; 20130204-A, Exp 5/4/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Ketorolac Injection, all strengths and all presentations including a) Ketorolac 30 mg/mL 10 mL MDV, b) Ketorolac 30 mg/mL 2 mL SDV, c) Ketorolac 30 mg/mL 1 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Ketorolac 30 mg/mL 10 mL: 20130327-B, Exp 6/27/2013; b) Ketorolac 30 mg/mL 2 mL: 20130326-B, Exp 6/26/2013; 20130307-C, Exp 6/7/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs L-Carnitine Injection, all strengths and all presentations including L-Carnitine 500 mg/mL 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130402-G, Exp 7/2/2013; 20130129-H, Exp 4/29/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs L-Glutathione Injection, all strengths and all presentations including a) L-Glut-100 mg-30 mL, b) L-Glut-200 mg/30 mL, c) Glutathione 200 mg/ML P.F. 10 mL, d) L-Glutathione-200-30 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) L-Glut-100 mg-30 mL: 20130213-D, Exp 5/13/2013; b) L-Glut-200 mg/30 mL: 20130318-J, Exp 6/18/2013; 20130301-C, Exp 6/1/2013 ; d) L-Glutathione-200-30 mL, 30 mL: 20130205-A 5/5/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Lidocaine Injection, all strengths and all presentations including a) Lidocaine _HCl-0.5%, b) Lidocaine HCl, c) Lidocaine 1%, d) Lidocaine 1% 50 mL, e) Lidocaine 2 %, f) Lidocaine 2% 50 mL, g) Lidocaine 2% 50 mL MDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Lidocaine _HCl-0.5%: 20130403-J, 20130403-F, 20130403-H, 20130403-G, 20130403-I, Exp 7/3/2013; 2013117-I, Exp 4/17/2013; b) Lidocaine HCl: 20130131-H, Exp 4/30/2013; c) Lidocaine 1%: 20130204-N, Exp 5/4/2013; 20130115-A, Exp 4/15/2013; 20130128-E, Exp 4/28/2013; 20130220-G, Exp 5/20/2013; 20130221-J, Exp 5/21/2013; 20130221-K, Exp 5/21/2013; 20130204-J, Exp 5/4/2013; 20130315-J, Exp 6/15/2013; 20130315-K, Exp 6/15/2013; 20130328-E, Exp 6/28/2013; 20130328-H, Exp 6/28/2013; 20130328-I, Exp 6/28/2013; 20130328-K, Exp 6/28/2013; 20130329-B, Exp 6/29/2013; 20130329-C, Exp 6/29/2013; 20130304-K, Exp 6/4/2013; 20130304-L, Exp 6/4/2013; 20130305-L, Exp 6/5/2013; 20130305-D, Exp 6/5/2013; 20130306-H, Exp 6/6/2013; 20130306-P, Exp 6/6/2013; 20130307-J, Exp 6/7/2013; 20130115-B, Exp 4/15/2013; 20130201-M, Exp 5/1/2013; 20130214-A, Exp 5/14/2013; 20130204-M, Exp 5/4/2013; 20130328-F, Exp 6/28/2013; 20130329-A, Exp 6/29/2013; 20130305-M, Exp 6/5/2013; 20130305-D, Exp 6/5/2013; 20130328-J, Exp 6/28/2013; d) Lidocaine 1% 50 ml: 20130128-D, 4/28/2013; 20130115-D, Exp 4/15/2013; 20130115-F, Exp 4/15/2013; 20130117-H, Exp 4/17/2013; 20130115-C, Exp 4/15/2013; e) Lidocaine 2 %: 20130325-F, Exp 6/25/2013; 20130130-N, Exp 4/30/2013; 20130221-L, Exp 5/21/2013; 20130221-N, Exp 5/21/2013; 20130228-I, Exp 5/28/2013; 20130314-H, Exp 6/14/2013; 20130314-I, Exp 6/14/2013; 20130315-E, Exp 6/15/2013; 20130315-F, Exp 6/15/2013; 20130318-K, Exp 6/18/2013; 20130320-D, Exp 6/20/2013; 20130320-B, Exp 6/20/2013; 0130328-D, Exp 6/28/2013; 20130328-G, Exp 6/28/2013; 20130305-E, Exp 6/5/2013; 20130130-M, Exp 4/30/2013; 20130221-M, Exp 5/21/2013; 20130221-O, Exp 5/21/2013; 20130325-E, Exp 6/25/2013; f) Lidocaine 2% 50ml: 20130320-C, Exp 6/20/2013; 20130305-F, Exp 6/5/2013; 20130305-I, Exp 6/5/2013; 20130301-A, Exp 6/1/2013; 20130304-L, Exp 6/4/2013; g) Lidocaine 2% 50ml MDV: 20130227-E, Exp 5/27/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Lipotropic With Vitamin Injections, all strengths and all presentations including a) Lipo W/ Vitamin 100 mL, b) Lipo W/ Vitamins 30 mL, c) Lipo W/Vitamin, d) Lipo w/Vitamins #5 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Lipo W/ Vitamin 100 mL: 20130322-D, Exp 6/22/2013; 20130115-H, Exp 4/15/2013; b) Lipo W/ Vitamins 30 mL: 20130228-H, Exp 5/28/2013; 20130228-H, Exp 5/28/2013; 20130322-D, Exp 6/22/2013; 20130208-J, Exp 5/8/2013; c) Lipo W/Vitamin: 20130228-H, Exp 5/28/2013; d) Lipo w/Vitamins #5 30 mL: 201301281000IN, Exp 4/28/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Lipotropic With Vitamins with Methylcobalamin Injections, all strengths and all presentations including a) Lipo w/Vitamins-methylcobalamin 100 mL, 30 mL, and b) Lipo w/ Vitamins, Folic, Methylcobalamin 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Lipo w/Vitamins-methylcobalamin 100 mL: 20130225-A, Exp 5/25/2013; 20130326-D, Exp 6/26/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs L-Lysine Injection, all strengths and all presentations including a) L-Lysine_100-30 mL, b) L-Lysine_100 mg/30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) L-Lysine_100-30 mL: 130117300AE, Exp 4/17/2013; 20130118-F, Exp 4/18/2013; 20130129-G, Exp 4/29/2013; 20130131-G, Exp 4/30/2013; b) L-Lysine_100 mg/30 mL: 20130405-E, Exp 7/5/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Magnesium Chloride Injection, all strengths and all presentations including a) Magnesium Chloride 200 mg/50 mL and b) Magnesium Chloride 200 mg/mL 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Magnesium Chloride 200 mg/50 mL: 20130321-F, Exp 6/21/2013; 20130319-I, Exp 6/19/2013; b) Magnesium Chloride 200 mg/mL 50mL: 20130307-F, Exp 6/7/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Magnesium Sulfate Injection, all strengths and all presentations including a) Magnesium Sulfate 50%; b) MAGNESIUM SULFATE 50% 50 mL, c) Magnesium Sulfate PF 50% 2 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Magnesium Sulfate 50%: 20130130-F, Exp 4/30/2013; 20130128-F, Exp 4/28/2013; 20130221-T, Exp 5/21/2013; b) MAGNESIUM SULFATE 50% 50 mL: 20130322-E, Exp 6/22/2013; 20130219-C, Exp 5/19/2013; 20130307-A, Exp 6/7/2013; 20130404-G, Exp 7/4/2013; c) Magnesium Sulfate PF 50% 2 mL: 20130227-F, Exp 5/27/2013; 20130312-G, Exp 6/12/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Manganese Sulfate Injection, all strengths and all presentations including a) Manganese-0.1 30 mL, b) Manganese Sulfate 0.1 mg/30 mL, c) Manganese Sulfate 5 mg/5 mg, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Manganese-0.1 30 mL: 20130129500JN, Exp 4/29/2013; 1301302000AE, Exp 4/30/2013; b) Manganese Sulfate 0.1 mg/30 mL: 20130405-G, Exp 7/5/2013; c) Manganese Sulfate 5 mg/5 mL: 20130122-4, Exp 4/22/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Medroxyprogesterone Acetate Injection, all strengths and all presentations including a) Medroxyprogesterone 150-30 mL, b) Medroxyprogesterone Acetate 150 mg/mL in 1 mL, 10 mL, 30 mL vials, c) Medroxyprogesterone Acetate 150 mg/mL PF syringe, d) Medroxyprogesterone Acetate 150 mg/mL syringe, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Medroxyprogesterone 150-30 mL: 20130301-H, Exp 6/1/2013. Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Methylcobalamin Injection, all strengths and all presentations including a) Methylcobalamin 1000 mcg/mL in 10 mL, 30 mL, 50 mL, 60 mL, b) Methylcobalamin 1000 mcg 30 mL, c) Methylcobalamin 5 mg/mL 30 mL, d) Methylcobalamin PF 1000 mcg/mL in 2 mL, 5 mL, 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Methylcobalamin 1000 mcg: 20130208-G, Exp 5/8/2013; 20130118-G, Exp 4/18/2013; 20130129-E, Exp 4/29/2013; 20130212-B, Exp 5/12/2013; 20130221-I , Exp 5/21/2013; 20130206-D, Exp 5/6/2013; 20130301-E, Exp 6/1/2013; 20130305-C, Exp 6/5/2013; b) Methylcobalamin 1000 mcg 30 mL: 20130308-G, Exp 6/8/2013; c) Methylcobalamin 5 mg/30 mL: 20130214-I, Exp 5/14/2013; d) Methylcobalamin PF 1000 mcg: 20130312-G, Exp 6/12/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Methylprednisolone Acetate and Marcaine Injection, all strengths and all presentations including a) Methylpred 80 mg/mL and Marcaine 0.25%-2.75, b) Methylpred_Marc-0.25-0.27, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot#: a) Methylpred 80 mg/mL and Marcaine 0.25%-2.75: 130312200GV3, Exp 6/12/13; b) Methylpred_Marc-0.25-0.27: 13011536, Exp 4/15/2013; 20130226-GV2, Exp 5/26/2013; 13012335GV4, Exp 4/23/2013; 13012460GV2, Exp 4/24/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Methylprednisolone and Dexamethasone Injection, all strengths and all presentations including a) Methylpred/ Dexameth 1-2-3 mL and b) Methylpred/Dexa 3 mL PFS; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Methylpred/ Dexameth 1-2-3 mL: 13040150GV1, Exp 7/1/2013; 13032750GV3, Exp 6/27/2013; b) Methylpred/Dexa 3 mL PFS: 13032050GV4, Exp 6/20/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Methylprednisolone and Bupivacaine Injection, all strengths and all presentations including Methylpred80mg/bupivacaine0.25% syr; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 13012335-GV4, Exp 4/23/2013;; 20130226-GV2, Exp 5/26/2013; 130312200GV3, Exp 6/12/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Methylprednisolone, Lidocaine, and Sodium Chloride Injection, all strengths and all presentations including a) Methylpred-Lido-Nacl-1-5-6-12 syringe and b) Methylpred80mg/lido1%/Sodium Chloride0.9% syr; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Methylpred-Lido-Nacl-1-5-6-12 syringe: 20120226-GV3, Exp 5/26/2013; 13012370GV3, Exp 4/23/2013; 13012480, Exp 4/24/2013; 13011550, Exp 4/15/2013; b) Methylpred80mg/lido1%/Sodium Chloride0.9% syr: 13012370-GV3, Exp 4/23/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Lipotropic With Vitamins, Carnitine, Chromium and Glutamine Injection, all strengths and all presentations including Lipo W/Vitamin-Carn-Crom_Glut-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 130305600AE, Exp 6/5/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Methylprednisolone Acetate Injection, all strengths and all presentations including a) Methylprednisolone Acetate 40 mg/mL, b) Methylprednisolone Acetate (PF) 40 mg/mL, c) Methylprednisolone Acetate (PF) 80 mg/mL, d) Methylpred Acetate 40 mg/mL 1 mL, e) Methylprednisolone 80 mg/5 mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. a) Methylprednisolone Acetate 40 mg/mL: 20130228-E, Exp 5/28/2013; 2013012370-GV3, Exp 4/23/2013; 20130318-D, Exp 6/18/2013; b) Methylprednisolone Acetate (PF) 40 mg/mL: 20130219-B, Exp 5/19/2013; 20130315-B, Exp 6/15/2013; c) Methylprednisolone Acetate (PF) 80 mg/mL: 201303131-A, Exp 6/13/2013; 20130304-M, Exp 6/4/2013; 20130405-A, Exp 7/5/2013; 20130214-G, Exp 5/14/2013; d) Methylpred Acetate 40 mg/mL 1 mL: 20130318-D, Exp 6/18/2013; e) Methylprednisolone 80 mg/5 mL: 20130214-G, Exp 5/14/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Metoprolol Injection, all strengths and all presentations including Metoprolol 1 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130130-B, Exp 4/30/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs MIC Vitamin Injection, all strengths and all presentations including a) MIC 25-50-25-30 mL, b) MIC_B_COMP-B12-25-50-50-1000-30 mL, c) MIC_B12-25-50-25-400-30 mL, d) MIC_B6_B12-30 mL, e) MIC_METH_VIT-#3-30 m, f) MIC_METH-25-50-50-1000 mcg 30 mL, g) MIC_ULTRA-30 mL, h) MIC_VIT_METH_CARN-12.5-25-25-1-25-30 mL, i) MIC-25-50-25 Cyano 1000 mcg/mL 30 mL, j) MIC-25-50-50-30 mL, k) MIC-8-15-15-30, l) MIC-B12-30, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) MIC 25-50-25-30 mL: 20130130-D, Exp 4/30/2013; 20130214-F, Exp 5/14/2013; b) MIC_B_COMP-B12-25-50-50-1000-30 mL: 1303261000AE, Exp 6/26/2013; c) MIC_B12-25-50-25-400-30 mL: 20130307-I, Exp 6/7/2013; 20120206-H, Exp 5/6/2013; d) MIC_B6_B12-30 mL: 20130208-E, Exp 5/8/2013; e) MIC_METH_VIT-#3-30 mL: 1302072000AE, Exp 5/7/2013; f) MIC_METH-25-50-50-1000 mcg 30 mL: 20130326-G, Exp 6/26/2013; g) MIC_ULTRA-30 mL: 20130220-I, Exp 5/20/2013; h) MIC_VIT_METH_CARN-12.5-25-25-1-25-30 mL: 1302081000AE, Exp 5/8/2013; 20130327-C, Exp 6/27/2013; i) MIC-25-50-25 Cyano 1000 mcg/mL 30mL: 1303261000AE, Exp 6/26/2013; j) MIC-25-50-50-30 mL; 20130213-E, Exp 5/13/2013; k) MIC-8-15-15-30: 20130118-C, Exp 4/18/2013; 20130318-F, Exp 6/18/2013; l) MIC-B12-30: 20130114-C, Exp 4/14/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Modified Myers Cocktail Injection, all strengths and all presentations including a) Mod Meyer's Cocktail 37 mL and b) Modified Myers Cocktail 37 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) 20130321-E, Exp 6/21/2013; b) 20130215-F, Exp 5/15/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Nandrolone Decanoate Injection, all strengths and all presentations including a) Nandrolone Decanoate 300 mg/mL, b) Nandrolone 200 mg/mL, c) Nandrolone 250 mg/mL, d) Nandrolone 350 mg/mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Nandrolone Decanoate 300 mg/mL: 20130311-J, Exp 6/11/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Phenylephrine Injection, all strengths and all presentations including Phenylephrine 1% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130129-F, Exp 4/29/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Phosphatidylcholine and Sodium Deoxycholate Injection, all strengths and all presentations including Phospha_Deoxy-35-30-50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 201303071500JN, Exp 6/7/2013; 1301231000AE, Exp 4/23/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Polidocanol Injection, all strengths and all presentations including a) Polidocanol 5% 30 mL, b) Polidocanol 1% 30 mL, c) Polidocanol 2% 30 mL, d) Polidocanol 3% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: Polidocanol 5% 30 mL: 20130319-I, Exp 6/19/2013; 20130326-H, Exp 6/26/2013; b) Polidocanol 1% 30 mL: 20130118-B, Exp 4/18/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Procaine Hydrochloride Injection, all strengths and all presentations, including a) Procaine 2% 30 mL PF, b) Procaine HCl 2% 10 mL, c) Procaine HCl 20 mg/mL 30 mL, d) Procaine HCl 1% 50 mL MDV, e) Procaine HCl 1% PF 5 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) 20130405-B, Exp 7/5/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Progesterone Injection, all strengths and all presentations including a) Progesterone 100 mg/mL 10 mL, 30 mL b) Progesterone 50 mg/mL 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Progesterone 100 mg/mL 10 mL: 20130306-E, Exp 6/6/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Pyridoxine Hydrochloride Injection, all strengths and all presentations including Pyridoxine 100 mg/mL 30 mL, 50 mL, and 10 mL PF SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130130-J, Exp 4/30/2013; 20130225-D, Exp 5/25/2013; 20130315-I, Exp 6/15/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Sodium Chloride and Dexamethasone Injection, all strengths and all presentations including a) SOD_CHLOR-DEXAMETH-0.9-10-3, b) SOD_CHLORIDE/DEXAMETH syringe 0.9-10-3, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) SOD_CHLOR-DEXAMETH-0.9-10-3: 13011450GV3, Exp 4/14/2013; 13011450GV2, Exp 4/14/2013; 13011760A, Exp 4/17/2013; 13012440, Exp 4/24/2013; 13020425GV2, Exp 5/4/2013; 2013021950GV1, Exp 5/19/2013; b) SOD_CHLORIDE/DEXAMETH syringe 0.9-10-3: 13031330GV1, Exp 6/13/2013; 13031460GV1, Exp 6/14/2013; 13032740GV2, Exp 6/27/2013; 20130327GV1, Exp 6/27/2013; 13021920GV1, Exp 5/19/2013; 130301100GV3, Exp 6/1/2013; 20130222GV2, Exp 5/22/2013; 13020850GV1, Exp 5/8/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Sodium Bicarbonate and Lidocaine Injection, all strengths and all presentations including Sod-Bicarb-Lido-0.27-2.73-3 syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130226-GV4, Exp 5/26/2013; 13031150GV3, Exp 6/11/2013; 13031240GV4, Exp 6/12/2013; 13012325GV5, Exp 4/23/2013; 13021820GV3, Exp 5/18/2013; 13011520, Exp 4/15/2013; 13012425GV1, Exp 4/24/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Nandrolone Decanoate and Testosterone Cypionate Injection, all strengths and all presentations including a) Nandrolone 100 mg/mL TestCyp 100 mg/mL 10 mL and b) Nandrolone 100 mg/mL TestCyp 200 mg/mL 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Nandrolone 100 mg/mL TestCyp 100 mg/mL 10 mL: 130220060AE, Exp 5/20/13 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Sodium Bicarbonate Injection, all strengths and all presentations including: a) Sodium Bicarb 4.2% 5 mL PF, b) Sodium Bicarb 8.4% 50 mL SDV, c) Sodium Bicarbonate 8.4%, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: Sodium Bicarb 4.2% 5 mL PF: 130123150AE, Exp 4/23/2013; b) Sodium Bicarb 8.4% 50 mL SDV: 20130315-L, Exp 6/15/2013; c) Sodium Bicarbonate 8.4%: 20130117-D, Exp 4/17/2013; 20130117-E, Exp 4/17/2013; 20130117-F, Exp 4/17/2013; 20130121-B, Exp 4/21/2013; 20130121-C, Exp 4/21/2013; 20130121-D, Exp 4/21/2013; 20130121-E, Exp 4/21/2013; 20130121-F, Exp 4/21/2013; 20130121-H, Exp 4/21/2013; 20130121-I, Exp 4/21/2013; 20130121-J, Exp 4/21/2013; 20130121-K, Exp 4/21/2013; 20130124-D, Exp 4/24/2013; 20130124-E, Exp 4/24/2013; 20130129-B, Exp 4/29/2013; 20130129-C, Exp 4/29/2013; 20130129-D, Exp 4/29/2013; 20130129-K, Exp 4/29/2013; 20130129-L, Exp 4/29/2013; 20130129-M, Exp 4/29/2013; 20130131-I, Exp 4/30/2013; 20130131-J, Exp 4/30/2013; 20130131-K, Exp 4/30/2013; 20130201-B, Exp 5/1/2013; 20130201-C, Exp 5/1/2013; 20130211-A, Exp 5/11/2013; 20130211-B, Exp 5/11/2013; 20130211-C, Exp 5/11/2013; 20130211-D, Exp 5/11/2013; 20130211-E, Exp 5/11/2013; 20130211-F, Exp 5/11/2013; 20130211-G, Exp 5/11/2013; 20130211-H, Exp 5/11/2013; 20130211-I, Exp 5/11/2013; 20130211-J, Exp 5/11/2013; 20130211-K, Exp 5/11/2013; 20130211-L, Exp 5/11/2013; 20130211-N, Exp 5/11/2013; 20130211-O, Exp 5/11/2013; 20130211-P, Exp 5/11/2013; 20130211-Q, Exp 5/11/2013; 20130211-R, Exp 5/11/2013; 20130211-S, Exp 5/11/2013; 20130211-T, Exp 5/11/2013; 20130214-D, Exp 5/14/2013; 20130214-E, Exp 5/14/2013; 20130214-H, Exp 5/14/2013; 20130215-A, Exp 5/15/2013; 20130215-B, Exp 5/15/2013; 20130215-D, Exp 5/15/2013; 20130215-E, Exp 5/15/2013; 20130215-G, Exp 5/15/2013; 20130215-H, Exp 5/15/2013; 13021840GV3, Exp 5/18/2013; 20130219-G, Exp 5/19/2013; 20130219-H, Exp 5/19/2013; 20130219-I, Exp 5/19/2013; 20130219-J, Exp 5/19/2013; 20130221-B, Exp 5/21/2013; 20130221-A, Exp 5/21/2013; 20130221-E, Exp 5/21/2013; 20130221-F, Exp 5/21/2013; 20130221-G, Exp 5/21/2013; 20130221-H, Exp 5/21/2013; 20130221-P, Exp 5/21/2013; 20130221-Q, Exp 5/21/2013; 20130221-S, Exp 5/21/2013; 20130222-B, Exp 5/22/2013; 20130222-C, Exp 5/22/2013; 20130225-E, Exp 5/25/2013; 20130225-F, Exp 5/25/2013; 20130225-G, Exp 5/25/2013; 201302256-GV4, Exp 5/25/2013; 20130227-P, Exp 5/27/2013; 20130227-Q, Exp 5/27/2013; 20130227-R, Exp 5/27/2013; 20130227-S, Exp 5/27/2013; 20130227-T, Exp 5/27/2013; 20130228-F, Exp 5/28/2013; 20130228-G, Exp 5/28/2013; 20130204-I, Exp 5/4/2013; 20130205-D, Exp 5/5/2013; 20130205-E, Exp 5/5/2013; 20130205-F, Exp 5/5/2013; 20130206-E, Exp 5/6/2013; 20130206-F, Exp 5/6/2013; 20130206-I, Exp 5/6/2013; 20130206-J, Exp 5/6/2013; 20130206-K, Exp 5/6/2013; 20130206-L, Exp 5/6/2013; 20130207-C, Exp 5/7/2013; 20130207-D, Exp 5/7/2013; 20130207-E, Exp 5/7/2013; 20130301-B, Exp 6/1/2013; 20130312-A, Exp 6/12/2013; 20130312-B, Exp 6/12/2013; 20130312-C, Exp 6/12/2013; 20130312-D, Exp 6/12/2013; 13031240GV4, Exp 6/12/2013; 20130313-J, Exp 6/13/2013; 20130313-K, Exp 6/13/2013; 20130314-G, Exp 6/14/2013; 20130314-L, Exp 6/14/2013; 20130314-M, Exp 6/14/2013; 20130315-L, Exp 6/15/2013; 20130315-M, Exp 6/15/2013; 20130315-N, Exp 6/15/2013; 20130318-H, Exp 6/18/2013; 20130319-D, Exp 6/19/2013; 20130319-K, Exp 6/19/2013; 20130319-L, Exp 6/19/2013; 20130320-G, Exp 6/20/2013; 20130320-H, Exp 6/20/2013; 20130320-I, Exp 6/20/2013; 20130320-J, Exp 6/20/2013; 20130320-K, Exp 6/20/2013; 20130320-L, Exp 6/20/2013; 20130325-I, Exp 6/25/2013; 20130325-J, Exp 6/25/2013; 20130325-L, Exp 6/25/2013; 20130325-M, Exp 6/25/2013; 20130325-N, Exp 6/25/2013; 20130327-D, Exp 6/27/2013; 20130327-E, Exp 6/27/2013; 20130327-F, Exp 6/27/2013; 20130327-G, Exp 6/27/2013; 20130327-H, Exp 6/27/2013; 20130327-I, Exp 6/27/2013; 20130327-J, Exp 6/27/2013; 20130327-K, Exp 6/27/2013; 20130327-L, Exp 6/27/2013; 20130327-M, Exp 6/27/2013; 20130327-N, Exp 6/27/2013; 20130329-D, Exp 6/29/2013; 20130329-E, Exp 6/29/2013; 20130329-F, Exp 6/29/2013; 20130329-G, Exp 6/29/2013; 20130304-B, Exp 6/4/2013; 20130304-C, Exp 6/4/2013; 20130304-D, Exp 6/4/2013; 20130304-E, Exp 6/4/2013; 20130304-F, Exp 6/4/2013; 20130304-G, Exp 6/4/2013; 20130304-H, Exp 6/4/2013; 20130304-I, Exp 6/4/2013; 20130306-A, Exp 6/6/2013; 20130306-B, Exp 6/6/2013; 20130306-C, Exp 6/6/2013; 20130306-D, Exp 6/6/2013; 20130306-I, Exp 6/6/2013; 20130306-J, Exp 6/6/2013; 20130306-K, Exp 6/6/2013; 20130308-A, Exp 6/8/2013; 20130308-B, Exp 6/8/2013; 20130308-C, Exp 6/8/2013; 20130308-D, Exp 6/8/2013; 20130308-E, Exp 6/8/2013; 20130308-F, Exp 6/8/2013; 20130401-D, Exp 7/1/2013; 20130401-E, Exp 7/1/2013; 20130401-F, Exp 7/1/2013; 20130404-B, Exp 7/4/2013; 20130404-C, Exp 7/4/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Sodium Chloride Injection, all strengths and all presentations including a) Bacteriostatic Sodium Chloride 0.9% 30 mL, b) Sodium Chloride 23.4% 30 mL PF, and c) Sodium Chloride 23.4% 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Bacteriostatic Sodium Chloride 0.9% 30 mL, 20121205, Exp 6/11/2013; b) Sodium Chloride 23.4% 30 mL PF: 20130115-G, Exp 4/15/2013; c) Sodium Chloride 23.4% 50 mL: 20130114-E, Exp 4/14/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Sodium Tetradecyl Sulfate Injection, all strengths and all presentations including a) Sodium Tetradecyl Sulfate 3% 50 mL, b) Sodium Tetradecyl Sulfate 3% mL, c) Sodium Tetradecyl Sulfate-2% 30 mL, d) Sodium Tetradecyl Sulfate-2.5% 20 mL, e) Sodium Tetradecyl Sulfate 0.3% 30 mL, f) Sodium Tetradecyl Sulfate 1% 30 mL, 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Sodium Tetradecyl 3% 50 mL: 20130318-G, Exp 6/18/2013; b) Sodium Tetradecyl 3% mL: 20130218-G, Exp 5/18/2013; c) Sodium Tetradecyl-2% 30 mL: 20130122-B, Exp 4/22/2013; d) Sodium Tetradecyl-2.5% 20 mL: 20130114-D, Exp 4/14/2013; 20130117-C, Exp 4/17/2013 . Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Testosterone Cypionate and Testosterone Propionate Injection, all strengths and all presentations including a) Testosterone cyp 200/test prop 20 mg 10 mL and b) Testosterone Cyp 200 mg/Test Prop 50 mg 10mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Testosterone cyp 200/test prop 20 mg 10 mL: 130102500AE, Exp 4/25/2013; b) Testosterone Cyp 200 mg/Test Prop 50 mg 10 mL: 20130305-1, Exp 6/5/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Taurine Injection, all strengths and all presentations including a) Taurine 50 mg/mL, b) Taurine-50-30 mL, c) Taurine-50 mg-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: Taurine 50 mg/mL: 20130305-A, Exp 6/5/2013; Taurine-50-30 mL: 20130123-D, Exp 4/23/2013; Taurine-50mg-30 mL: 21030117-J, Exp 4/17/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Testosterone Propionate, Testosterone Cypionate, and Nandrolone Decanoate Injection, all strengths and all presentations including Test Prop 100 mg/Test Cyp 50 mg/nandro dec 150 mg/ml, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130122-G, Exp 4/22/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Testosterone Cypionate Injection, all strengths and all presentations including a) Testosterone Cyp 200 mg/10 mL; b) Testosterone Cypionate 100 mg/10mL; c) Testosterone Cypionate 200 mg 10 mL; d) Testosterone Cypionate 200 mg 30 mL; e) Testosterone Cypionate 200 mg/mL; f) Testosterone Cypionate 200 mg/mL 30 mL; g) Testosterone Cypionate Sesame 200 mg/10 mL; h) Testosterone Cyp 250/30 mL; i) Testosterone Cypionate 200 mg/mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Testosterone Cyp 200 mg/10 mL: 20130128-A, Exp 4/28/2013; b) Testosterone Cypionate 100 mg/10 mL: 20130226-G, Exp 5/26/2013; 130402100AE, Exp 7/2/2013; c) Testosterone Cypionate 200 mg 10 mL: 20130220-A, Exp 5/20/2013; 20130306-L, Exp 6/6/2013; 20130221-C, Exp 5/21/2013; 20130320-A, Exp 6/20/2013; 20130403-B, Exp 7/3/2013; 20130208-A, Exp 5/8/2013; 20130215-C, Exp 5/15/2013; d) Testosterone Cypionate 200 mg 30 mL: 20130208-A, Exp 5/8/2013; 20130121-A, Exp 4/21/2013; 20130129-A, Exp 4/29/2013; 20130221-C, Exp 5/21/2013; 20130314-J, Exp 6/14/2013; 20130318-O, Exp 6/18/2013; 20130326-A, Exp 6/26/2013; 20130220-A, Exp 5/20/2013; 20130402-E, Exp 7/2/2013; e) Testosterone Cypionate 200 mg/mL: 20130304-J, Exp 6/4/2013; f) Testosterone Cypionate 200 mg/mL 30 mL: 20130215-C, Exp 5/15/2013; g) Testosterone Cypionate Sesame 200 mg/10 mL: 20130405-C, Exp 7/5/2013; h) Tetosterone Cyp 250/30 mL: 20130118-A, Exp 4/18/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Thiamine Hydrochloride Injection, all strengths and all presentations including a) Thiamine 100 mg/30 mL, b) Thiamine Hydrochloride 100 mg/mL with preservative 30 mL, c) Thiamine Hydrochloride 50 mg/mL with preservative 30 mL, d) Thiamine Hydrochloride 100 mg/mL preservative free 10 mL and 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Thiamine 100 mg/30 mL: 20130130-G, Exp 4/30/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Triamcinolone Injection, all strengths and all presentations including a) Triamcinolone 40 mg/1 mL PF, b) Triamcinolone Acetonide 45 mg/mL, c) Triamcinolone 50 mg/mL 5 mL PF, d) Triamcinolone 45 mg/mL10 mL, 30 mL, e) Triamcinolone 40 mg/mL SDV PF 1 mL, 2 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Triamcinolone 40 mg/1 mL PF: 20130314-K, Exp 6/14/2013;b) Triamcinolone Acetonide 45 mg/mL: 20130129-I, Exp 4/29/2013; 20130208-B, Exp 5/8/2013; 20130314-K, Exp 6/14/2013; 20130318-E, Exp 6/18/2013; 20130308-1, Exp 6/8/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Zinc Sulfate Injection, all strengths and all presentations including a) Zinc Sulfate 10 mg/mL 30 mL and b) Zinc Sulfate 1 mg/mL 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Zinc Sulfate 10 mg/30 mL: 20130404-A, Exp 7/4/2013; b) Zinc Sulfate 1 mg/10 mL: 20130206-B, Exp 5/6/2013 . Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Devices BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. Used for culturing microorganisms. Model number 221239: lot 2348199 with expiration date 4/5/13; and model number 221261: lot 2348208 with expiration date 3/22/13, lot 2355145 with expiration date 4/2/13, lot 2339019 with expiration date 4/5/13, lot 2348157 with expiration date 4/6/13, lot 2361011 with expiration date 4/6/13, lot 2348202 ,with expiration date 4/6/13, lot 2348108 with expiration date 4/12/13, lot 2348074 with expiration date 4/19/13, and lot 3038371 with expiration date 5/28/13 Class II Microbiological media may be contaminated with bacteria. Becton Dickinson & Co.
Devices BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate. Used for culturing microorganisms. Model number 221291: lot 2355138 with expiration date 3/6/13, lot 2355164 with expiration date 3/8/13 Class II Microbiological media may be contaminated with bacteria. Becton Dickinson & Co.
Devices BBL(tm) CDC Anaerobe 5% Sheep Blood Agar. Used for culturing microorganisms. Model number 221733: lot 2361003 with expiration date 3/14/13 Class II Microbiological media may be contaminated with bacteria. Becton Dickinson & Co.
Devices Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas. The large distance of more than 16mm between cannula ends and posterior pole guarantees sufficient light in the working area and a large observation field especially when used in conjunction with modern wide field panoramic observation systems. Lot Numbers: M53157, M55115, M56929, M58551, M61862. Class II Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic Cannula due to a misclassification of the medical device. Insight Instruments, Inc.
Devices Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit. Product 80530: 032887164, 203184264,110983764, 208286764, 116480564, 221590564, 120987864, 236385564,127085464; Product 8508: 207383964, 23489464 Class III On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits. Covidien LLC
Devices Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit. 103387264, 117881264, 110983964, 214981164, 117488864 Class III On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits. Covidien LLC
Food Island Mix, 12 oz. with best by date of 02/17/2014 Best by Date of 02/17/2014 Class II Incorrect labeling and undeclared allergens , including Peanuts, Cashews, Almonds, Consumers who have an allergy or sensitivity to peanuts, Cashews, Almonds run the risk of serious or life-threatening allergic reactions. The product Island Mix packaged in a clear bag (dried fruit mixture) contained Peanuts, Cashews, Almonds. Nuts Are Good! Inc.
Devices Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series. Part Number 800-3104. Lot Number 153-12. Expiration date: Jan 2013 Class II The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. This results in the instrument not passing controls and the customer not being able to run patient samples. Iris Diagnostics
Food Dried Mango (3.5oz.), S&M(HK) Enterprise LTD, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Distributed By: S&M Int'l Inc. 100 Pulaski Street, Bayonne, NJ 07002. Product of China. Item No. 802578. All lots Class II The recall was initiated after it was discovered through NYDAM Sampling which revealed the product Dried Mango contains undeclared sulfites/preservatives. S & M International Inc
Food Grove Grow Notes Hawthorne , 400 Gram (14 oz.), S&M(HK) Enterprise LTD, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Deputy: S&M (USA) Enterprise 4703 2nd Avenue, Brooklyn, NY 11232. Product of China. All lots Class II The recall was initiated after it was discovered through NYDAM Sampling which revealed the product Grove Grow Notes Hawthorne contains unallowed dye 16255,Ponceau 4R (E124)- Acid Red 18 and FD& C Yellow #5 S & M International Inc
Food Tasty Snacks Sour Plum, (6 oz.), S&M(HK) Enterprise LTD, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Distributed By: S&M Int'l Inc. 100 Pulaski Street, Bayonne, NJ 07002. Product of China. Item No. 802578. All lots Class II The recall was initiated after it was discovered through NYDAM Sampling which revealed the product Tasty Snacks Sour Plum contains undeclared sulfites/preservatives, contains unallowed dye:16185-Amaranth (E123)-Acid Red 27 and contains undeclared FD & C Yellow #6 S & M International Inc
Food Lam Sheng Kee Chinese Red Dates, (Net Weight 400 Grams), Lam Sheng Kee (HK) International Limited, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Distributed By: S&M Int'l Inc. 100 Pulaski Street, Bayonne, NJ 07002. Item #803810; Product of China. All lots Class III The recall was initiated after it was discovered through NYDAM Sampling which revealed the product Lam Sheng Kee Red Dates contain unallowed dye basic violet 3. S & M International Inc
Food Lam Sheng Kee Mini Sausage Hong Kong Style, Net Weight 6.3 oz.), Lam Sheng Kee (HK) International Limited, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Distributed By: S&M Int'l Inc. 100 Pulaski Street, Bayonne, NJ 07002. All lots Class III The recall was initiated after it was discovered through NYDAM Sampling which revealed the product Lam Sheng Kee Mini Sausage contains undeclared FD&C Red #40 and undeclared minced fish (unknown fish species) S & M International Inc
Devices Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays. Analytes claimed with this lot of Liquichek ToRCH Plus IgM Control: · Cytomegalovirus (CMV) IgM · Herpes Simplex Virus Type 1/2 (HSV-1/2) IgM · Rubella Virus IgM · Toxoplasma gondii IgM Lot Number 18972, Catalog Number 229 and 229PX. Class III The Liquichek" ToRCH Plus IgM Control - Positive, contains detectable levels of HCV RNA which originated from the non-specific human IgM component used in the mouse monoclonal antibody conjugation process for this product. Bio-rad Laboratories, Inc.
Drugs Walmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY. Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR. Packaged by: Legacy Pharmaceutical Packaging, LLC, Earth City, MO. NDC 68645-445-70. Lot # 130251, 130252, 130253 Exp date: 11/14 Class II Labeling: Labeling Error on Declared Strength; product label incorrectly states Amlodipine 5 mg instead of Amlodipine 10 mg. Tablet strength is 10 mg Legacy Pharmaceutical Packaging LLC
Devices Zilver® PTX® Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps Preven the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to:  Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD .  improve blood flow to the extremity. REF ZIV6-35-125-6-80-PTX ; REFG24890 UDI 10827002248905 All lots distributed prior to 4/16/2013 Class I Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death, occurred in cases where a tip separation was reported. Cook, Inc.
Devices Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps prevent the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to: Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD. Improve blood flow to the extremity. REF ZIV6-35-125-7-80-PTX ; UDI 10827002248950 all lots distributed through 4/16/13 Class I Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death, occurred in cases where a tip separation was reported. Cook, Inc.
Devices Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer. Serial numbers H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387 Class II Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target. Varian Medical Systems, Inc.
Drugs Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- count bottle (NDC 68462-127-05), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India, Manufactured for : Glenmark Generics USA Mahwah, NJ 07430. a) 600mg: Lot# 02123419, Exp 10/14 Lot# 02123424, Exp 10/14 Lot# 02123430, Exp 10/14 Lot# 02123492, Exp 10/14 Lot# 02123523, Exp 10/14 Lot# 02123527, Exp 10/14 Lot# 02123532, Exp 10/14 Lot# 02123542, Exp 10/14 Lot# 02123546, Exp 10/14 Lot# 02123551, Exp 10/14 Lot# 02123555, Exp 10/14 Lot# 02123560, Exp 11/14 Lot# 02123566, Exp 11/14 Lot# 02123569, Exp 11/14 b) 800 mg Lot# 02123440 Exp 10/14 Lot# 02123445 Exp 10/14 Lot# 02123454 Exp 10/14 Lot# 02123465 Exp 10/14 Lot# 02123789 Exp 11/14 Lot# 02123804 Exp 11/14 Lot# 02123821 Exp 11/14 Lot# 02123829 Exp 11/14 Lot# 02123834 Exp 11/14 Lot# 02123841 Exp 11/14 Lot# 02123845 Exp 11/14 Class III Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature. Glenmark Generics Inc., USA
Drugs Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for :Glenmark Generics USA Mahwah, NJ 07430 Lot # 02121059 Exp 03/15 Lot # 02121484 Exp 04/15 Lot # 02121530 Exp 04/15 Lot# 02121665 Exp 05/15 Lot# 02121669 Exp 05/15 Lot# 02121689 Exp 05/15 Lot# 02121705 Exp 05/15 Lot# 02123434 Exp 10/15 Lot# 02123446 Exp 10/15 Lot# 02123633 Exp 11/15 Lot# 02123677 Exp 11/15 Lot# 02123685 Exp 11/15 Lot# 02123695 Exp 11/15 Lot# 02123823 Exp 11/15 Lot# 02123833 Exp 11/15 Lot# 02123836 Exp 11/15 Lot# 02123853 Exp 11/15 Lot# 02123859 Exp 11/15 Lot# 02130021 Exp 12/15 Lot# 02130059 Exp 12/15 Lot# 02130079 Exp 12/15 Class III Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature. Glenmark Generics Inc., USA
Drugs Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for : Glenmark Generics USA Mahwah, NJ 07430 Lot# 02123782, Exp 11/14 Class III Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature. Glenmark Generics Inc., USA
Devices Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27,H29, HCX, Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. CODES: H140001 H140064 H140137 H140721 H140796 H140862 H260947 H270267 H270428 H270539 H270708 H270828 H271017 H140002 H140065 H140139 H140723 H140797 H140863 H260949 H270271 H270430 H270540 H270709 H270829 H271018 H140003 H140066 H140141 H140724 H140798 H140865 H260950 H270273 H270431 H270542 H270710 H270833 H271019 H140004 H140067 H140143 H140725 H140799 H140866 H260951 H270277 H270435 H270544 H270711 H270836 H271020 H140005 H140068 H140144 H140726 H140800 H140868 H260952 H270280 H270437 H270547 H270712 H270837 H271021 H140006 H140069 H140145 H140727 H140801 H140869 H260953 H270281 H270438 H270550 H270714 H270838 H271023 H140007 H140070 H140146 H140729 H140803 H140871 H270004 H270282 H270439 H270601 H270716 H270840 H271024 H140008 H140071 H140147 H140731 H140804 H140872 H270006 H270285 H270443 H270602 H270718 H270841 H271026 H140009 H140073 H140148 H140733 H140805 H140873 H270009 H270290 H270445 H270607 H270719 H270842 H271031 H140010 H140074 H140150 H140734 H140806 H140874 H270010 H270293 H270446 H270613 H270725 H270844 H271032 H140011 H140075 H140151 H140737 H140807 H140877 H270021 H270297 H270447 H270615 H270726 H270845 H271034 H140012 H140077 H140152 H140738 H140808 H140878 H270026 H270302 H270448 H270622 H270727 H270846 H271035 H140014 H140078 H140153 H140739 H140809 H140879 H270027 H270303 H270451 H270623 H270728 H270852 H271037 H140015 H140080 H140154 H140740 H1408095 H140882 H270029 H270307 H270452 H270624 H270732 H270854 H271038 H140016 H140082 H140201 H140742 H140810 H140883 H270030 H270310 H270454 H270625 H270733 H270855 H271039 H140017 H140083 H140202 H140743 H140811 H140885 H270038 H270314 H270455 H270627 H270735 H270857 H271041 H140018 H140084 H140203 H140744 H140812 H140886 H270045 H270323 H270458 H270631 H270736 H270858 H271043 H140019 H140086 H140204 H140745 H140813 H140889 H270047 H270324 H270461 H270632 H270737 H270859 H271044 H140021 H140088 H140206 H140746 H140814 H140890 H270073 H270329 H270462 H270633 H270739 H270861 H271051 H140022 H140090 H140207 H140747 H140815 H140891 H270079 H270332 H270464 H270634 H270740 H270863 H271052 H140023 H140092 H140208 H140748 H140816 H140892 H270088 H270335 H270466 H270635 H270746 H270864 H271055 H140024 H140093 H140209 H140749 H140817 H140893 H270094 H270337 H270470 H270637 H270749 H270865 H271056 H140025 H140095 H140210 H140750 H140819 H140896 H270096 H270338 H270473 H270639 H270751 H270866 H271059 H140026 H140096 H140212 H140751 H140820 H140897 H270101 H270341 H270474 H270641 H270752 H270867 H271061 H140027 H140097 H140213 H140754 H140822 H140907 H270106 H270344 H270476 H270643 H270755 H270868 H271062 H140028 H140098 H140214 H140755 H140823 H140908 H270107 H270345 H270477 H270644 H270757 H270869 H271063 H140029 H140099 H140215 H140756 H140824 H140909 H270110 H270351 H270479 H270645 H270762 H270870 H271066 H140030 H140100 H140217 H140757 H140825 H140914 H270111 H270352 H270482 H270646 H270766 H270871 H271068 H140032 H140101 H140218 H140758 H140826 H140917 H270118 H270353 H270483 H270647 H270767 H270872 H271071 H140033 H140102 H140219 H140760 H140827 H140918 H270126 H270355 H270486 H270648 H270769 H270873 H271072 H140034 H140103 H140220 H140761 H140828 H140919 H270128 H270356 H270487 H270649 H270777 H270875 H271075 H140035 H140105 H140222 H140762 H140829 H140920 H270134 H270360 H270489 H270651 H270781 H270877 H271076 H140036 H140106 H140223 H140764 H140830 H140921 H270136 H270364 H270490 H270652 H270782 H270878 H271079 H140037 H140107 H140228 H140765 H140834 H140922 H270138 H270365 H270491 H270653 H270783 H270879 H271080 H140038 H140108 H140229 H140766 H140835 H140925 H270144 H270370 H270495 H270654 H270785 H270880 H271082 H140039 H140110 H140231 H140767 H140836 H140927 H270201 H270371 H270498 H270656 H270786 H270881 H271083 H140040 H140111 H140232 H140768 H140838 H140928 H270209 H270373 H270499 H270660 H270787 H270882 H271085 H140041 H140113 H140233 H140769 H140839 H140934 H270211 H270378 H270500 H270661 H270788 H270883 H271086 H140042 H140114 H140234 H140770 H140840 H260905 H270215 H270383 H270501 H270662 H270789 H270884 H271088 H140043 H140115 H140235 H140772 H140841 H260909 H270216 H270384 H270502 H270665 H270793 H270885 H271091 H140044 H140116 H140236 H140773 H140842 H260916 H270219 H270385 H270503 H270667 H270794 H270886 H271092 H140045 H140117 H140237 H140774 H140843 H260917 H270227 H270386 H270504 H270669 H270796 H270888 H271094 H140046 H140118 H140239 H140776 H140844 H260922 H270228 H270391 H270505 H270670 H270800 H270889 H271095 H140047 H140120 H140240 H140777 H140845 H260923 H270229 H270392 H270506 H270675 H270801 H270891 H271097 H140048 H140121 H140700 H140778 H140847 H260924 H270230 H270395 H270508 H270680 H270803 H270892 H271098 H140049 H140123 H140701 H140780 H140848 H260925 H270232 H270398 H270511 H270681 H270804 H270894 H271099 H140050 H140124 H140702 H140781 H140849 H260926 H270235 H270399 H270512 H270682 H270805 H270895 H271100 H140052 H140125 H140703 H140782 H140850 H260928 H270240 H270400 H270513 H270684 H270806 H270896 H271101 H140053 H140127 H140704 H140783 H140851 H260930 H270244 H270401 H270516 H270685 H270812 H270897 H271102 H140054 H140128 H140705 H140785 H140853 H260931 H270245 H270410 H270518 H270686 H270813 H270898 H271103 H140056 H140129 H140706 H140786 H140854 H260932 H270251 H270412 H270520 H270690 H270817 H270899 H271104 H140057 H140130 H140709 H140787 H140855 H260936 H270252 H270416 H270522 H270692 H270820 H271002 H271105 H140058 H140131 H140711 H140788 H140856 H260938 H270254 H270418 H270525 H270693 H270821 H271004 H271107 H140059 H140132 H140712 H140789 H140857 H260939 H270255 H270419 H270526 H270697 H270822 H271005 H271108 H140060 H140133 H140713 H140791 H140858 H260940 H270256 H270421 H270529 H270698 H270823 H271009 H271109 H140061 H140134 H140716 H140793 H140859 H260942 H270260 H270425 H270532 H270699 H270825 H271013 H271110 H140062 H140135 H140718 H140794 H140860 H260944 H270261 H270426 H270534 H270700 H270826 H271015 H271112 H140063 H140136 H140719 H140795 H140861 H260946 H270264 H270427 H270535 H270705 H270827 H271016 H271113 H271114 H271212 H271292 H271369 H271443 H271516 H271588 H271659 H271731 H271803 H271876 H271947 H272020 H271115 H271214 H271293 H271370 H271444 H271517 H271589 H271660 H271732 H271804 H271878 H271948 H272021 H271116 H271216 H271294 H271371 H271445 H271518 H271590 H271662 H271733 H271807 H271879 H271949 H272022 H271117 H271217 H271295 H271372 H271447 H271519 H271591 H271663 H271734 H271808 H271880 H271950 H272023 H271120 H271218 H271296 H271373 H271448 H271520 H271592 H271664 H271735 H271809 H271882 H271951 H272024 H271121 H271219 H271297 H271374 H271449 H271521 H271594 H271667 H271736 H271810 H271883 H271952 H272025 H271125 H271222 H271298 H271375 H271450 H271522 H271595 H271669 H271737 H271812 H271884 H271955 H272026 H271127 H271223 H271300 H271376 H271451 H271523 H271596 H271670 H271738 H271813 H271885 H271956 H272027 H271131 H271224 H271302 H271377 H271452 H271525 H271597 H271671 H271739 H271814 H271886 H271957 H272028 H271132 H271225 H271303 H271378 H271453 H271526 H271598 H271672 H271740 H271815 H271887 H271958 H272029 H271135 H271226 H271304 H271379 H271454 H271527 H271599 H271673 H271741 H271816 H271889 H271959 H272030 H271136 H271227 H271305 H271380 H271455 H271528 H271600 H271674 H271742 H271817 H271890 H271960 H272032 H271137 H271228 H271306 H271381 H271456 H271529 H271601 H271675 H271743 H271818 H271891 H271961 H272033 H271142 H271229 H271308 H271382 H271457 H271530 H271602 H271676 H271744 H271819 H271892 H271962 H272034 H271143 H271230 H271309 H271383 H271458 H271531 H271603 H271677 H271746 H271820 H271893 H271963 H272036 H271144 H271231 H271311 H271384 H271459 H271532 H271604 H271678 H271748 H271822 H271894 H271964 H272037 H271145 H271233 H271312 H271386 H271460 H271533 H271605 H271680 H271749 H271824 H271895 H271965 H272038 H271149 H271234 H271314 H271390 H271461 H271534 H271606 H271682 H271750 H271825 H271896 H271966 H272039 H271151 H271235 H271315 H271392 H271462 H271535 H271608 H271683 H271751 H271827 H271897 H271967 H272040 H271152 H271236 H271316 H271393 H271464 H271536 H271609 H271684 H271752 H271829 H271898 H271968 H272041 H271153 H271238 H271317 H271394 H271465 H271538 H271610 H271685 H271753 H271830 H271899 H271969 H272043 H271154 H271239 H271318 H271395 H271466 H271539 H271611 H271686 H271754 H271831 H271901 H271970 H272046 H271155 H271241 H271319 H271397 H271467 H271540 H271612 H271687 H271755 H271832 H271902 H271971 H272047 H271157 H271243 H271320 H271398 H271468 H271541 H271613 H271688 H271756 H271833 H271903 H271972 H272048 H271158 H271245 H271321 H271399 H271470 H271542 H271614 H271689 H271757 H271834 H271904 H271973 H272049 H271160 H271247 H271322 H271401 H271472 H271543 H271615 H271691 H271758 H271835 H271905 H271974 H272051 H271161 H271248 H271323 H271402 H271473 H271544 H271616 H271692 H271759 H271836 H271906 H271975 H272052 H271162 H271249 H271324 H271403 H271474 H271545 H271617 H271693 H271760 H271837 H271907 H271976 H272053 H271165 H271250 H271325 H271404 H271475 H271546 H271618 H271695 H271761 H271838 H271908 H271977 H272054 H271166 H271251 H271327 H271406 H271476 H271547 H271619 H271696 H271762 H271839 H271909 H271979 H272055 H271167 H271253 H271328 H271407 H271477 H271548 H271621 H271698 H271763 H271840 H271910 H271981 H272056 H271172 H271256 H271329 H271408 H271478 H271551 H271622 H271699 H271764 H271841 H271911 H271982 H272057 H271174 H271257 H271331 H271409 H271479 H271552 H271624 H271700 H271765 H271842 H271912 H271983 H272060 H271176 H271258 H271332 H271410 H271481 H271553 H271626 H271701 H271766 H271843 H271913 H271984 H272061 H271177 H271259 H271333 H271411 H271483 H271554 H271627 H271702 H271768 H271844 H271914 H271985 H272062 H271178 H271260 H271334 H271412 H271484 H271555 H271628 H271703 H271769 H271845 H271916 H271986 H272063 H271179 H271262 H271335 H271413 H271485 H271558 H271629 H271704 H271770 H271846 H271917 H271988 H272064 H271182 H271263 H271337 H271414 H271487 H271559 H271630 H271705 H271771 H271847 H271918 H271989 H272066 H271184 H271264 H271338 H271415 H271488 H271561 H271631 H271706 H271772 H271849 H271919 H271990 H272068 H271185 H271265 H271339 H271416 H271490 H271562 H271632 H271707 H271773 H271850 H271920 H271992 H272069 H271186 H271266 H271340 H271417 H271491 H271563 H271633 H271708 H271774 H271851 H271921 H271993 H272070 H271187 H271267 H271342 H271419 H271493 H271564 H271634 H271709 H271775 H271852 H271922 H271994 H272071 H271189 H271268 H271343 H271420 H271494 H271565 H271635 H271710 H271776 H271855 H271924 H271996 H272073 H271190 H271269 H271344 H271421 H271495 H271566 H271636 H271711 H271777 H271856 H271925 H271997 H272074 H271191 H271270 H271345 H271422 H271497 H271567 H271637 H271712 H271778 H271857 H271926 H271999 H272075 H271192 H271272 H271347 H271423 H271498 H271568 H271638 H271713 H271779 H271858 H271927 H272000 H272076 H271193 H271273 H271349 H271424 H271499 H271570 H271639 H271714 H271780 H271859 H271928 H272001 H272077 H271194 H271274 H271350 H271425 H271500 H271571 H271640 H271715 H271781 H271860 H271929 H272002 H272078 H271195 H271276 H271351 H271426 H271501 H271572 H271641 H271716 H271782 H271861 H271930 H272003 H272080 H271196 H271277 H271353 H271428 H271502 H271573 H271642 H271717 H271783 H271862 H271931 H272004 H272081 H271197 H271278 H271355 H271429 H271503 H271574 H271643 H271718 H271785 H271863 H271932 H272005 H272082 H271198 H271280 H271356 H271430 H271504 H271575 H271647 H271719 H271786 H271864 H271933 H272006 H272083 H271199 H271281 H271357 H271431 H271505 H271576 H271648 H271720 H271788 H271866 H271934 H272007 H272084 H271200 H271282 H271358 H271433 H271506 H271577 H271649 H271721 H271789 H271867 H271936 H272010 H272086 H271201 H271283 H271359 H271434 H271507 H271578 H271650 H271722 H271790 H271868 H271937 H272011 H272087 H271202 H271284 H271361 H271435 H271508 H271580 H271651 H271723 H271791 H271869 H271938 H272012 H272088 H271204 H271285 H271362 H271436 H271509 H271581 H271653 H271724 H271792 H271870 H271939 H272013 H272089 H271205 H271286 H271363 H271437 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H290258 H272103 H272177 H272245 H272319 H272394 H272465 H272855 H272946 H273038 H273124 H273209 H290175 H290259 H272104 H272178 H272247 H272321 H272395 H272466 H272856 H272947 H273039 H273125 H273381 H290176 H290260 H272106 H272179 H272248 H272322 H272396 H272467 H272861 H272948 H273040 H273126 H273509 H290180 H290261 H272107 H272180 H272249 H272323 H272398 H272470 H272862 H272950 H273041 H273127 H273547 H290181 H290262 H272108 H272181 H272250 H272325 H272399 H272473 H272863 H272951 H273043 H273128 H273711 H290182 H290264 H272109 H272182 H272251 H272326 H272400 H272475 H272864 H272954 H273044 H273130 H273929 H290183 H290265 H272110 H272183 H272253 H272327 H272401 H272476 H272865 H272957 H273046 H273132 H274683 H290185 H290266 H272111 H272184 H272254 H272328 H272402 H272477 H272866 H272958 H273050 H273135 H274684 H290186 H290267 H272112 H272185 H272255 H272329 H272403 H272478 H272867 H272959 H273051 H273136 H274798 H290187 H290268 H272113 H272186 H272256 H272330 H272404 H272479 H272868 H272960 H273052 H273137 H283374 H290189 H290269 H272114 H272187 H272257 H272331 H272406 H272480 H272869 H272961 H273053 H273138 H290001 H290191 H290270 H272116 H272188 H272258 H272332 H272407 H272484 H272870 H272962 H273054 H273139 H290003 H290192 H290271 H272117 H272189 H272259 H272335 H272408 H272488 H272871 H272963 H273056 H273141 H290004 H290193 H290272 H272118 H272190 H272260 H272336 H272409 H272489 H272875 H272965 H273059 H273142 H290014 H290194 H290273 H272119 H272191 H272261 H272337 H272410 H272490 H272876 H272966 H273061 H273143 H290026 H290195 H290274 H272121 H272192 H272262 H272338 H272411 H272491 H272878 H272967 H273064 H273144 H290027 H290196 H290275 H272122 H272193 H272263 H272339 H272412 H272492 H272879 H272968 H273065 H273145 H290030 H290197 H290276 H272123 H272194 H272264 H272340 H272413 H272493 H272881 H272971 H273066 H273147 H290031 H290198 H290277 H272124 H272195 H272266 H272341 H272414 H272495 H272882 H272972 H273067 H273148 H290032 H290201 H290278 H272125 H272196 H272267 H272342 H272415 H272496 H272885 H272974 H273068 H273149 H290033 H290202 H290280 H272126 H272197 H272268 H272343 H272416 H272497 H272886 H272975 H273069 H273150 H290034 H290203 H290281 H272127 H272198 H272269 H272344 H272417 H272500 H272887 H272976 H273071 H273152 H290105 H290205 H290282 H272128 H272199 H272271 H272345 H272418 H272800 H272888 H272979 H273072 H273153 H290108 H290206 H290283 H272129 H272200 H272272 H272347 H272419 H272803 H272890 H272980 H273074 H273155 H290109 H290208 H290284 H272131 H272201 H272274 H272348 H272420 H272805 H272891 H272981 H273075 H273156 H290110 H290209 H290286 H272132 H272202 H272276 H272349 H272422 H272806 H272892 H272982 H273077 H273157 H290111 H290211 H290288 H272134 H272203 H272277 H272350 H272423 H272807 H272893 H272983 H273078 H273158 H290113 H290212 H290289 H272136 H272204 H272279 H272351 H272424 H272808 H272894 H272985 H273079 H273159 H290114 H290214 H290290 H272137 H272205 H272280 H272352 H272426 H272809 H272895 H272986 H273080 H273160 H290116 H290216 H290291 H272139 H272206 H272281 H272355 H272428 H272811 H272896 H272987 H273081 H273162 H290118 H290217 H290292 H272140 H272207 H272282 H272356 H272431 H272812 H272897 H272988 H273082 H273163 H290121 H290219 H290293 H272141 H272208 H272283 H272357 H272432 H272813 H272898 H272989 H273083 H273164 H290122 H290220 H290295 H272142 H272209 H272284 H272358 H272433 H272814 H272899 H272990 H273084 H273165 H290123 H290221 H290296 H272143 H272210 H272285 H272359 H272434 H272815 H272900 H272991 H273085 H273166 H290125 H290222 H290297 H272144 H272211 H272286 H272360 H272435 H272816 H272902 H272993 H273086 H273167 H290128 H290223 H290299 H272145 H272215 H272287 H272361 H272436 H272817 H272903 H272994 H273087 H273168 H290130 H290224 H290302 H272146 H272216 H272288 H272363 H272437 H272818 H272905 H272995 H273088 H273169 H290132 H290225 H290304 H272147 H272217 H272289 H272364 H272438 H272820 H272906 H273000 H273089 H273170 H290135 H290226 H290305 H272148 H272218 H272290 H272366 H272439 H272821 H272907 H273002 H273090 H273172 H290137 H290227 H290306 H272149 H272220 H272291 H272367 H272440 H272822 H272908 H273005 H273093 H273173 H290138 H290229 H290307 H272150 H272221 H272293 H272369 H272441 H272823 H272909 H273011 H273094 H273175 H290139 H290230 H290308 H272151 H272222 H272294 H272371 H272442 H272824 H272913 H273012 H273097 H273176 H290141 H290232 H290309 H272152 H272223 H272295 H272372 H272443 H272825 H272914 H273013 H273098 H273178 H290143 H290233 H290310 H272153 H272224 H272296 H272373 H272444 H272829 H272916 H273014 H273099 H273179 H290144 H290234 H290311 H272154 H272226 H272299 H272374 H272445 H272830 H272917 H273016 H273100 H273180 H290145 H290235 H290312 H272155 H272227 H272300 H272376 H272446 H272831 H272918 H273018 H273101 H273181 H290151 H290236 H290313 H272156 H272228 H272301 H272377 H272447 H272833 H272919 H273019 H273102 H273182 H290152 H290238 H290314 H272160 H272229 H272302 H272379 H272448 H272834 H272920 H273020 H273103 H273183 H290154 H290239 H290315 H272161 H272230 H272303 H272380 H272449 H272836 H272923 H273021 H273105 H273185 H290155 H290240 H290316 H272163 H272232 H272305 H272381 H272450 H272838 H272924 H273022 H273108 H273186 H290156 H290241 H290317 H272164 H272233 H272306 H272382 H272451 H272839 H272925 H273023 H273109 H273188 H290157 H290242 H290318 H272165 H272234 H272307 H272383 H272452 H272840 H272926 H273024 H273111 H273189 H290158 H290243 H290320 H272166 H272235 H272308 H272384 H272453 H272841 H272927 H273025 H273112 H273191 H290159 H290244 H290321 H272167 H272236 H272309 H272385 H272455 H272842 H272930 H273028 H273113 H273192 H290160 H290246 H290322 H272168 H272237 H272310 H272386 H272456 H272844 H272932 H273029 H273114 H273197 H290161 H290247 H290323 H272169 H272238 H272311 H272387 H272457 H272845 H272933 H273030 H273115 H273198 H290162 H290248 H290324 H272170 H272239 H272313 H272388 H272458 H272846 H272934 H273031 H273117 H273199 H290164 H290250 H290325 H272096 H272171 H272240 H272314 H272389 H272460 H272850 H272936 H273032 H273118 H273200 H290165 H290253 H272097 H272173 H272241 H272315 H272390 H272461 H272851 H272937 H273033 H273119 H273201 H290166 H290255 H272098 H272174 H272242 H272316 H272391 H272462 H272852 H272939 H273034 H273121 H273204 H290168 H290256 H272100 H272175 H272243 H272317 H272392 H272463 H272853 H272940 H273035 H273122 H273205 H290171 H290257 H272101 H272176 H272244 H272318 H272393 H272464 H272854 H272942 H273037 H273123 H273206 H290173 H290258 H272103 H272177 H272245 H272319 H272394 H272465 H272855 H272946 H273038 H273124 H273209 H290175 H290259 H272104 H272178 H272247 H272321 H272395 H272466 H272856 H272947 H273039 H273125 H273381 H290176 H290260 H272106 H272179 H272248 H272322 H272396 H272467 H272861 H272948 H273040 H273126 H273509 H290180 H290261 H272107 H272180 H272249 H272323 H272398 H272470 H272862 H272950 H273041 H273127 H273547 H290181 H290262 H272108 H272181 H272250 H272325 H272399 H272473 H272863 H272951 H273043 H273128 H273711 H290182 H290264 H272109 H272182 H272251 H272326 H272400 H272475 H272864 H272954 H273044 H273130 H273929 H290183 H290265 H272110 H272183 H272253 H272327 H272401 H272476 H272865 H272957 H273046 H273132 H274683 H290185 H290266 H272111 H272184 H272254 H272328 H272402 H272477 H272866 H272958 H273050 H273135 H274684 H290186 H290267 H272112 H272185 H272255 H272329 H272403 H272478 H272867 H272959 H273051 H273136 H274798 H290187 H290268 H272113 H272186 H272256 H272330 H272404 H272479 H272868 H272960 H273052 H273137 H283374 H290189 H290269 H272114 H272187 H272257 H272331 H272406 H272480 H272869 H272961 H273053 H273138 H290001 H290191 H290270 H272116 H272188 H272258 H272332 H272407 H272484 H272870 H272962 H273054 H273139 H290003 H290192 H290271 H272117 H272189 H272259 H272335 H272408 H272488 H272871 H272963 H273056 H273141 H290004 H290193 H290272 H272118 H272190 H272260 H272336 H272409 H272489 H272875 H272965 H273059 H273142 H290014 H290194 H290273 H272119 H272191 H272261 H272337 H272410 H272490 H272876 H272966 H273061 H273143 H290026 H290195 H290274 H272121 H272192 H272262 H272338 H272411 H272491 H272878 H272967 H273064 H273144 H290027 H290196 H290275 H272122 H272193 H272263 H272339 H272412 H272492 H272879 H272968 H273065 H273145 H290030 H290197 H290276 H272123 H272194 H272264 H272340 H272413 H272493 H272881 H272971 H273066 H273147 H290031 H290198 H290277 H272124 H272195 H272266 H272341 H272414 H272495 H272882 H272972 H273067 H273148 H290032 H290201 H290278 H272125 H272196 H272267 H272342 H272415 H272496 H272885 H272974 H273068 H273149 H290033 H290202 H290280 H272126 H272197 H272268 H272343 H272416 H272497 H272886 H272975 H273069 H273150 H290034 H290203 H290281 H272127 H272198 H272269 H272344 H272417 H272500 H272887 H272976 H273071 H273152 H290105 H290205 H290282 H272128 H272199 H272271 H272345 H272418 H272800 H272888 H272979 H273072 H273153 H290108 H290206 H290283 H272129 H272200 H272272 H272347 H272419 H272803 H272890 H272980 H273074 H273155 H290109 H290208 H290284 H272131 H272201 H272274 H272348 H272420 H272805 H272891 H272981 H273075 H273156 H290110 H290209 H290286 H272132 H272202 H272276 H272349 H272422 H272806 H272892 H272982 H273077 H273157 H290111 H290211 H290288 H272134 H272203 H272277 H272350 H272423 H272807 H272893 H272983 H273078 H273158 H290113 H290212 H290289 H272136 H272204 H272279 H272351 H272424 H272808 H272894 H272985 H273079 H273159 H290114 H290214 H290290 H272137 H272205 H272280 H272352 H272426 H272809 H272895 H272986 H273080 H273160 H290116 H290216 H290291 H272139 H272206 H272281 H272355 H272428 H272811 H272896 H272987 H273081 H273162 H290118 H290217 H290292 H272140 H272207 H272282 H272356 H272431 H272812 H272897 H272988 H273082 H273163 H290121 H290219 H290293 H272141 H272208 H272283 H272357 H272432 H272813 H272898 H272989 H273083 H273164 H290122 H290220 H290295 H272142 H272209 H272284 H272358 H272433 H272814 H272899 H272990 H273084 H273165 H290123 H290221 H290296 H272143 H272210 H272285 H272359 H272434 H272815 H272900 H272991 H273085 H273166 H290125 H290222 H290297 H272144 H272211 H272286 H272360 H272435 H272816 H272902 H272993 H273086 H273167 H290128 H290223 H290299 H272145 H272215 H272287 H272361 H272436 H272817 H272903 H272994 H273087 H273168 H290130 H290224 H290302 H272146 H272216 H272288 H272363 H272437 H272818 H272905 H272995 H273088 H273169 H290132 H290225 H290304 H272147 H272217 H272289 H272364 H272438 H272820 H272906 H273000 H273089 H273170 H290135 H290226 H290305 H272148 H272218 H272290 H272366 H272439 H272821 H272907 H273002 H273090 H273172 H290137 H290227 H290306 H272149 H272220 H272291 H272367 H272440 H272822 H272908 H273005 H273093 H273173 H290138 H290229 H290307 H272150 H272221 H272293 H272369 H272441 H272823 H272909 H273011 H273094 H273175 H290139 H290230 H290308 H272151 H272222 H272294 H272371 H272442 H272824 H272913 H273012 H273097 H273176 H290141 H290232 H290309 H272152 H272223 H272295 H272372 H272443 H272825 H272914 H273013 H273098 H273178 H290143 H290233 H290310 H272153 H272224 H272296 H272373 H272444 H272829 H272916 H273014 H273099 H273179 H290144 H290234 H290311 H272154 H272226 H272299 H272374 H272445 H272830 H272917 H273016 H273100 H273180 H290145 H290235 H290312 H272155 H272227 H272300 H272376 H272446 H272831 H272918 H273018 H273101 H273181 H290151 H290236 H290313 H272156 H272228 H272301 H272377 H272447 H272833 H272919 H273019 H273102 H273182 H290152 H290238 H290314 H272160 H272229 H272302 H272379 H272448 H272834 H272920 H273020 H273103 H273183 H290154 H290239 H290315 H272161 H272230 H272303 H272380 H272449 H272836 H272923 H273021 H273105 H273185 H290155 H290240 H290316 H272163 H272232 H272305 H272381 H272450 H272838 H272924 H273022 H273108 H273186 H290156 H290241 H290317 H272164 H272233 H272306 H272382 H272451 H272839 H272925 H273023 H273109 H273188 H290157 H290242 H290318 H272165 H272234 H272307 H272383 H272452 H272840 H272926 H273024 H273111 H273189 H290158 H290243 H290320 H272166 H272235 H272308 H272384 H272453 H272841 H272927 H273025 H273112 H273191 H290159 H290244 H290321 H272167 H272236 H272309 H272385 H272455 H272842 H272930 H273028 H273113 H273192 H290160 H290246 H290322 H272168 H272237 H272310 H272386 H272456 H272844 H272932 H273029 H273114 H273197 H290161 H290247 H290323 H272169 H272238 H272311 H272387 H272457 H272845 H272933 H273030 H273115 H273198 H290162 H290248 H290324 H272170 H272239 H272313 H272388 H272458 H272846 H272934 H273031 H273117 H273199 H290164 H290250 H290325 H290327 H290400 H290547 H291065 H291146 H291241 H293341 H293412 H293502 H293581 H293669 H293756 H293836 H290328 H290401 H290549 H291066 H291147 H291243 H293342 H293414 H293503 H293585 H293670 H293758 H293837 H290329 H290402 H290550 H291067 H291148 H291245 H293343 H293418 H293504 H293586 H293671 H293760 H293838 H290330 H290403 H290551 H291068 H291149 H291246 H293344 H293419 H293505 H293588 H293672 H293761 H293839 H290332 H290404 H290552 H291069 H291150 H291247 H293345 H293420 H293506 H293590 H293673 H293762 H293841 H290333 H290405 H290555 H291073 H291153 H291248 H293348 H293421 H293507 H293592 H293675 H293763 H293844 H290334 H290406 H290556 H291074 H291154 H291249 H293350 H293423 H293508 H293595 H293676 H293764 H293845 H290335 H290408 H290557 H291075 H291155 H291250 H293351 H293424 H293509 H293596 H293677 H293765 H293846 H290336 H290409 H290558 H291079 H291156 H291251 H293352 H293425 H293512 H293597 H293678 H293769 H293848 H290337 H290410 H290559 H291080 H291159 H291252 H293353 H293427 H293513 H293598 H293679 H293770 H293849 H290338 H290411 H290560 H291081 H291160 H291254 H293354 H293429 H293514 H293599 H293682 H293771 H293850 H290339 H290412 H290561 H291082 H291162 H291255 H293355 H293430 H293515 H293600 H293683 H293772 H293851 H290340 H290413 H291002 H291083 H291166 H291256 H293356 H293431 H293518 H293601 H293684 H293773 H293852 H290342 H290414 H291003 H291085 H291168 H291257 H293357 H293432 H293519 H293602 H293689 H293774 H293855 H290343 H290415 H291005 H291086 H291170 H291258 H293358 H293433 H293520 H293603 H293691 H293776 H293856 H290344 H290416 H291006 H291087 H291171 H291261 H293359 H293434 H293521 H293605 H293692 H293778 H293857 H290345 H290417 H291007 H291088 H291172 H291263 H293360 H293436 H293523 H293606 H293693 H293780 H293858 H290346 H290422 H291009 H291089 H291174 H291264 H293361 H293437 H293524 H293609 H293694 H293781 H293859 H290347 H290423 H291010 H291090 H291175 H291265 H293362 H293438 H293525 H293610 H293695 H293783 H293860 H290348 H290424 H291011 H291091 H291178 H291267 H293364 H293439 H293527 H293611 H293696 H293784 H293861 H290349 H290427 H291012 H291093 H291179 H291269 H293365 H293443 H293528 H293612 H293697 H293785 H293862 H290350 H290500 H291013 H291094 H291180 H291270 H293366 H293444 H293529 H293613 H293702 H293786 H293864 H290351 H290501 H291014 H291095 H291181 H291271 H293367 H293445 H293530 H293614 H293703 H293787 H293865 H290352 H290502 H291015 H291096 H291182 H291272 H293368 H293446 H293531 H293615 H293705 H293788 H293866 H290353 H290504 H291016 H291097 H291183 H291273 H293369 H293447 H293532 H293616 H293707 H293789 H293868 H290354 H290505 H291017 H291099 H291186 H292832 H293370 H293449 H293534 H293617 H293708 H293790 H293869 H290355 H290506 H291018 H291101 H291188 H293009 H293372 H293450 H293535 H293618 H293709 H293791 H293870 H290356 H290507 H291021 H291102 H291190 H293300 H293373 H293451 H293538 H293620 H293710 H293792 H293871 H290357 H290508 H291022 H291103 H291191 H293301 H293374 H293452 H293539 H293621 H293713 H293793 H293873 H290358 H290510 H291024 H291104 H291193 H293302 H293375 H293453 H293540 H293622 H293714 H293794 H293874 H290359 H290511 H291025 H291105 H291194 H293303 H293376 H293454 H293541 H293623 H293715 H293795 H293875 H290360 H290512 H291027 H291106 H291195 H293304 H293378 H293455 H293542 H293626 H293716 H293796 H293876 H290362 H290513 H291028 H291107 H291196 H293306 H293379 H293456 H293543 H293627 H293717 H293797 H293877 H290363 H290514 H291029 H291108 H291198 H293308 H293380 H293457 H293544 H293629 H293718 H293798 H293878 H290364 H290515 H291030 H291109 H291200 H293309 H293381 H293458 H293545 H293631 H293719 H293799 H293879 H290365 H290516 H291031 H291111 H291201 H293310 H293382 H293459 H293546 H293632 H293720 H293800 H293880 H290366 H290517 H291034 H291112 H291202 H293311 H293383 H293460 H293548 H293634 H293721 H293802 H293881 H290367 H290518 H291035 H291114 H291203 H293312 H293384 H293463 H293549 H293635 H293723 H293803 H293882 H290368 H290519 H291036 H291115 H291205 H293313 H293385 H293466 H293550 H293637 H293725 H293805 H293884 H290369 H290520 H291039 H291116 H291206 H293314 H293386 H293467 H293551 H293638 H293726 H293806 H293885 H290371 H290521 H291040 H291117 H291208 H293315 H293387 H293470 H293552 H293639 H293727 H293807 H293886 H290373 H290522 H291041 H291119 H291209 H293317 H293389 H293471 H293553 H293640 H293728 H293808 H293887 H290377 H290524 H291042 H291120 H291212 H293318 H293390 H293475 H293554 H293641 H293729 H293809 H293888 H290378 H290525 H291044 H291121 H291214 H293319 H293391 H293476 H293555 H293642 H293730 H293813 H293889 H290379 H290526 H291045 H291122 H291215 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H294869 H295013 H293991 H294071 H294162 H294239 H294320 H294405 H294491 H294584 H294681 H294773 H294871 H295014 H293992 H294072 H294163 H294241 H294321 H294407 H294492 H294587 H294683 H294774 H294872 H295015 H293995 H294075 H294165 H294242 H294322 H294410 H294494 H294588 H294684 H294775 H294875 H295019 H293996 H294081 H294167 H294245 H294324 H294412 H294495 H294590 H294685 H294776 H294876 H295021 H293997 H294083 H294168 H294246 H294325 H294413 H294496 H294591 H294687 H294777 H294880 H295022 H293998 H294084 H294169 H294247 H294328 H294415 H294497 H294592 H294689 H294778 H294889 H295025 H293999 H294085 H294170 H294248 H294329 H294416 H294499 H294593 H294690 H294780 H294890 H295042 H294001 H294086 H294172 H294250 H294330 H294419 H294500 H294595 H294692 H294781 H294891 H295043 HCX3582 HCX4019 HCX4138 HCX4400 HCX4566 HCX4703 HCX4849 HCX4909 HCX4913 HCX4973 HCX4994 HCX5055 Class II Varian has identified that under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to approximately 7% before interlock occurs. At maximum asymmetry, this may result in no more than approximately 3.5% dose deviation from expected at any point in the beam, and may result in minor injury to the patient or slightly decreased local disease control. Varian Medical Systems, Inc. Oncology Systems
Food Early Bird Foods & Co. CHOC-A-DOODLE-DOO featuring DARK CHOCOLATE & COCONUT granola snack mix, Net Wt. 12 oz packaged in clear plastic bag. Each case contains 12 packages. UPC: 6 89466 30000 0. BEST ENJOYED BY: OCT 18 2013 Class II Early Bird Foods & Co. LLC is recalling CHOC-A-DOODLE-DOO featuring DARK CHOCOLATE & COCONUT granola snack mix due to Undeclared Soya lecithin. Early Bird Foods & Co., LLC
Devices GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures. 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005178429-0222 005178429-0235 00000007C20184 00000008C20042 00000408330BU9 00000520061BU3 00000520075BU3 00000007C20395 00000008C20090 00000008C20183 00000498685BU7 00000477833BU8 00000489764BU1 00000489778BU1 00000458498BU3 00000007C20136 00000007C20236 00000464579BU2 00000562718BU7 00000536796BU6 00000498683BU2 00000007C20168 00000007C20305 00000007C20363 00000046582BU1 00000466841BU4 0000010C2M0034 0000010C2M0109 00000007C20329 00000498680BU8 00000477841BU1 005178429-0034 0000009C2M0153 00000055098VE8 00000099665VE2 00000459665BU6 00000007C20014 00000536812BU1 00000007C20192 00000008C20022 0000009C2M0025 00000419206BU8 00000007C20163 0000009C2M0050 00000008C20315 00000536811BU3 00000007C20164 00000007C20368 00000008C20196 00000008C20254 00000008C20055 00000008C20175 00000007C20372 Class II While performing a fluoroscopic examination on the GE Innova systems, there is a potential of nonrecoverable loss of imaging modes with no advance warning, due to a relay failure in the power distribution box (PDB). Although no injuries have been reported due to this issue to date, there is risk of complications during the procedure as a result of imaging functionality loss. GE Healthcare, LLC
Devices Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul, MN 55121 Use to make an incision in the tympanic membrane. Lot No. 121012 Class II Summit Medical has initiated a recall of Myringotomy Lance Blade (Juvenile) because the box contains the wrong blade. The box contains Myringotomy Spear Blade (Juvenile). Summit Medical, Inc.
Food Grippo's Potato Chips, 1oz, 1 1/8oz , 1¾oz, 3.5oz, 8oz, 12oz bags & 1.5lb boxes, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT. www.grippopotatochips.com GRIPPO POTATO CHIP CO, INC. CINCINNATI, OH 45239 UPC: 0 76847 61701 5 Product Quantity Distributed: 1,410cs/60/1oz bags; 860cs/48/1 1/8oz bags; 5,802cs/24/1¾oz bags; 2,517cs/18/3.5oz bags; 11,701cs/6/Twin Pks; 2,009cs/9/8oz bags; 234cs/6/12oz bags; 71cs/36/1oz bags & 21,970/1.5# boxes. All bagged products with an expiration date of May 20th and prior, all 1.5# boxes with an expiration date of April 29 and prior. Class II During an inspection by the Ohio Department of Agriculture, the firm was notified of numerous metal fragments in the salt hopper. Grippo Potato Chip Co., Inc.
Food Grippo's BAR-B-Q FLAVORED POTATO CHIPS, 1oz, 1 1/8oz, 1¾oz, 3.5oz, 8oz, 12oz bags & 1.5lb boxes, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, SUGAR, TORULA YEAST, SPICES, MONOSODIUM GLUTAMATE, CORN FLOUR ONION POWDER, GARLIC POWDER, NATURAL HICKORY SMOKE FLAVOR, CARMEL COLOR, PAPRIKA EXTRACT, SILICON DIOXIDE. CONTAINS: SULFITES. www.grippopotatochips.com GRIPPO POTATO CHIP CO, INC. CINCINNATI, OH 45239 UPC: 0 76847 13131 3 Product Quantity Distributed: 19,685cs/60/1oz bags; 19,755cs/48/1 1/8oz bags; 56,217cs/24/1¾oz bags; 61,413cs/18/3.5oz bags; 88,940cs/6/Twin Pks; 59,790cs/9/8oz bags; 42,204cs/6/12oz bags; 73,685cs/36/1oz bags & 152,845/1.5# boxes. All bagged products with an expiration date of May 20th and prior, all 1.5# boxes with an expiration date of April 29 and prior. Class II During an inspection by the Ohio Department of Agriculture, the firm was notified of numerous metal fragments in the salt hopper. Grippo Potato Chip Co., Inc.
Food Grippo's Sweet BERMUDA ONION FLAVORED POTATO CHIPS, 1oz, 1¾oz, 3.5oz, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, SWEET BERMUDA ONION SEASONING***www.grippopotatochips.com GRIPPO POTATO CHIP CO, INC. CINCINNATI, OH 45239 UPC: 0 76847 61703 9 All bagged products with an expiration date of May 20th and prior. Class II During an inspection by the Ohio Department of Agriculture, the firm was notified of numerous metal fragments in the salt hopper. Grippo Potato Chip Co., Inc.
Food Grippo's Salt & Vinegar FLAVORED POTATO CHIPS, 1¾oz, 3.5oz, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, LACTOSE, SALT, DEXTROSE, SODIUM DIACETATE, MALIC ACID, AND NOT MORE THAN 2% SILICON DIOXIDE ADDED CONTAINS: MILK***www.grippopotatochips.com GRIPPO POTATO CHIP CO, INC. CINCINNATI, OH 45239 UPC: 0 76847 14125 1 All bagged products with an expiration date of May 20th and prior. Class II During an inspection by the Ohio Department of Agriculture, the firm was notified of numerous metal fragments in the salt hopper. Grippo Potato Chip Co., Inc.
Food Grippo's CHEDDAR CHEESE WITH A TOUCH OF JALAPENO natural & Artificially Flavored POTATO CHIPS, 1¾oz, 3.5oz, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, GRANULAR CHEESE (MILK, CHEESE CULTURES, SALT ENZYMES), MONOSODIUM GLUTAMATE, PARTIALLY HYDROGENATED SOYBEAN AND COTTONSEED OIL, SPICES, SUGAR, DEXTROSE, WHEY PROTEIN CONCENTRATE, LACTOSE MALTODEXTRIN, CITRIC ACID, BLUE CHEESE (MILK, CHEESE CULTURES, SALT, ENZYMES), SODIUM PHOSPHATE, CORN STARCH, YEAST EXTRACT, ONION, GARLIC, MODIFIED CORN STARCH, JALAPENO PEPPER, NATURAL AND ARTIFICIAL FLAVOR (CONTAINS MILK) ARTIFICIAL COLORS***LACTIC ACID AND NOT MORE THAN 2% SILICON DIOXIDE ADDED www.grippopotatochips.com GRIPPO POTATO CHIP CO, INC. CINCINNATI, OH 45239 UPC: 0 76847 14127 5 All bagged products with an expiration date of May 20th and prior. Class II During an inspection by the Ohio Department of Agriculture, the firm was notified of numerous metal fragments in the salt hopper. Grippo Potato Chip Co., Inc.
Food Grippo's HOT DILL PICKLE Artificially Flavored Potato Chips, 1¾oz, 3.5oz, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, WHEY, MALTODEXTRIN, MODIFIED CORN STARCH, SUGAR, MONOSODIUM GLUTAMATE, SODIUM DIACETATE, SPICES, ONION, GARLIC VINEGAR SOLIDS, NATURAL AND ARTIFICIAL FLAVOR, AND NOT MORE THAN 2% SILICON DIOXIDE ADDED www.grippopotatochips.com GRIPPO POTATO CHIP CO, INC. CINCINNATI, OH 45239 UPC: 0 7684714126 8 All bagged products with an expiration date of May 20th and prior. Class II During an inspection by the Ohio Department of Agriculture, the firm was notified of numerous metal fragments in the salt hopper. Grippo Potato Chip Co., Inc.
Food La Romanella Precooked Tri Color Cheese Tortellini, 2.5-lb bag Best By Dates: 12/25/2013, 1/15/2014, 3/15/2014, 4/2/2014, 4/13/2014, 4/15/2014, 4/16/2014, 5/20/2014, 6/1/2014, 6/3/2014, 7/9/2014, 7/19/2014, 7/29/2014, 8/8/2014, 8/26/2014, 9/9/2014, 9/16/2014, 9/17/2014, 10/2/2014 Class II No ingredient statement on pacakge. Product contains undeclared allergens: wheat, egg, and milk. SMART AND FINAL STORES CORP
Food CARSON'S HOMEMADE PIES AND OTHER GOOD THINGS brand FUDGE BROWNIE COOKIES, NET WT. 14 OZ., UPC 7 53182 15240 0 --- Corner Rt 31 + Rt 93, Lockport, NY 14094 - 716-433-2248 (phone) --- The cookies are packaged in clear, hard plastic containers with seven or eight cookies per container. --- INGREDIENTS: COOKIE: Flour, Sugar, Vegetable Shortening, Evaporated Milk, Eggs, Chocolate Chips, Cocoa, Baking Powder, Vanilla. FROSTING: Sugar, Vegetable Oil, Corn Syrup, Cocoa, Mono + Diglycerides, Polysorbate 60, Potassium Sorbate, Citric Acid, Lecithin, Salt, Flavorings. "Sell by Dates" of 4/26/2013 to 5/03/13 (date code can be found on the white sticker label found on the top of the hard plastic container) Class I Carson's Fudge Brownie Cookies contain undeclared walnuts, wheat (flour) and soy (lecithin). Carson's Country Market
Food CARSON'S HOMEMADE PIES AND OTHER GOOD THINGS brand ASSORTED COOKIE PACK Chocolate Chip - Fudge Brownie - Vanilla Drop - Molasses - Oatmeal Raisin - Peanut Butter - Pumpkin, NET WT. 14 OZ., UPC 7 53182 15240 0 --- Sanborn, NY 14132 --- The cookies are packaged in clear, hard plastic containers with seven or eight cookies per container. --- INGREDIENTS: Veg. Shortening, Flour, Sugar, Eggs, Vanilla. May Contain: Chocolate Chips, Cocoa, Peanut Butter, Milk (Evaporated), Molasses, Oatmeal, Baking Powder, Soda, Cinnamon, Nutmeg, Ginger Or Cloves. "Sell by Dates" of 4/26/2013 to 5/03/13 (date code can be found on the white sticker label found on the top of the hard plastic container) Class I Carson's Assorted Cookie Pack contains undeclared walnuts, wheat (flour), milk and peanut (butter). Carson's Country Market
Food Asia Best Salted Mackerel, 7 oz. vacuum packages, 25 pkgs/cases; labeled in part ***Eastland Food Corp. 8305 Stayton Drive Jessup, MD 20794 *** Product of Thailand *** Keep Frozen *** UPC 851035 408024*** Best Before - February 29, 2014 Class II Salted mackerel contains histamines at a level indicating product decomposition. Eastland Food Corporation
Devices DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique. Lot - D12178C Class III LifeLiner Stick and Cut Resistant Gloves are being recalled because cases and individual glove packages were mispackaged, with right handed, large sized glove packaging containing left handed, large sized gloves. DePuy Orthopaedics, Inc.
Devices PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring applications Lot Code Y092012-21, Manufacture Date 10/10/2012; Lot Code Y102612-12, Manufacture Date 11/17/2012; Lot Code Y110912-20, Manufacture Date 11/30/2012; Lot Code Y112912-10, Manufacture Date 12/22/2012; Lot Code Y121312-19, Manufacture Date 01/03/2013; Lot Code Y011013-13, Manufacture Date 01/29/2013; Lot Code Y012513-02, Manufacture Date 02/12/2013; Lot Code Y020713-05, Manufacture Date 02/26/2013; Lot Code Y021413-03, Manufacture Date 03/07/2013; Lot Code Y030113-04, Manufacture Date 03/23/2013 Class II ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device incapable of delivering the appropriate energy or shock to the patient and/or could cause potential injury to user or patient. ConMed Corporation
Food Senora Verde Taco Dinner Kit, 12ct, 9.75 oz (276g), 12 cartons per case. DA OCT 29 13 A 09:37 Class II The incorrect taco seasoning pouch, which contained wheat, was placed into the Senora Verde Taco Dinner Kit, which didn't declare wheat, so the product contained undeclared wheat. Gruma Corp
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