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U.S. Department of Health and Human Services

Enforcement Report - Week of February 13, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Food Yangchun Noodles, 10 case, 12 bgs per case no lot number available Class II Man Fon is recalling Yangchun Noodles because they contain undeclared wheat allergen. Man Fon Inc
Biologics Red Blood Cells 8913268; 8913269; 8912432; 8912431 Class II Blood products, which tested positive for viral testing but incorrectly entered as negative, were distributed. Community Blood Center of the Ozarks
Biologics Source Plasma 06FMOC6067; 06FMOC5647 Class II Blood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells Leukocytes Reduced GT94960; GT94963 Class III Blood products, collected using equipment for which quality control was not performed, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Blood and Blood Products for Reprocessing W141608611758 Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. Puget Sound Blood Center and Program
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W038308043344 Class II Blood product, which did not meet acceptable product specifications, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Source Plasma 06DTXC0849; 06DTXC1189; 06DTXC1646; 06DTXC2014; 06DTXC2293; 06DTXC2628; 06DTXC3411; 06DTXC3766; 06DTXC4035; 06DTXC4390; 06DTXC4690; 06DTXC5204; 06DTXC5270; 06DTXC5765; 06DTXC5861; 06DTXC6363; 06DTXC6450 ;06DTXC7035; 06DTXC7189; 06DTXC7633; 06DTXC7779; 06DTXC8263; 06DTXC8437; 06DTXC8971; 06DTXC9181; 06DTXC9678; 06DTXC9913; 06DTXD0550; 06DTXD0924; 06DTXD1252; 06DTXD1630; 06DTXD1957; 06DTXD2464; 06DTXD2662; 06DTXD2982; 06DTXD3357; 06DTXD3534; 06DTXD4236; 06DTXD4606; 06DTXD5024; 06DTXD5285; 06DTXD5560; 06DTXD5714; 07DTXA0102; 07DTXA0292; 07DTXA0585; 07DTXA0853; 07DTXA1019; 07DTXA1373; 07DTXA2109;  ...
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Class II Blood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells Leukocytes Reduced W141608044809; W141608049022. Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Puget Sound Blood Center and Program
Biologics Platelets Pooled W141608044809. Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Puget Sound Blood Center and Program
Biologics Source Plasma 037308105, 037308106, 037308107, 037308107A, 037308108, 037308109, 037308109A, 037308114A Class III Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed. Talecris Plasma Resources, Inc.
Biologics Red Blood Cells Leukocytes Reduced W038308076144 Class II Blood product, labeling/crossmatch tag incorrect or missing information was distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced W038308075650 Class II Blood product, which did not meet the acceptable product specifications, was distributed. Mississippi Valley Reg Bld Ctr
Drugs Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, LLC Seattle, WA 98101 U.S. Lic. No. 1791 NDC 58468-0181-2 B18511 Exp. 04/12 , B18513 Exp. 05/12, B18515 Exp. 06/12, B18517 Exp. 06/12, B18825 Exp. 10/12, B18831 Exp.12/12 Class III Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point. Bayer HealthCare Pharmaceuticals Inc.
Devices Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7). 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011 - Lots 5443576, 5522810, 5537042, 5557902 Class II Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event. Synthes USA HQ, Inc.
Devices Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7). Adjustable Drill Stop, Part Number 03.613.012 - Lots 5456424, 5494147, 5557938, and 5557939 Class II Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event. Synthes USA HQ, Inc.
Drugs SLIM XTREME Herbal Slimming Capsule, supplied in 30-count bottles. Another Product Forumulated and Distributed By: Globe All Wellness, LLC Hollywood, FL 33020 www.diet66.com Inquires Call 877.842.9873 All Lots of SlimXtreme with the following format stamped in black ink on the bottom of the bottle "MFD: XX.XX.20XX EXP: XX.XX.20XX", which were manufactured overseas, are being recalled. Class I Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug. Globe All Wellness, LLC
Food Siya Pan Gilori Net Wt. 180g. Distributed by: Miami Growers Inc. 80 Broadway Jersey City, NJ 07306 T 201-985-9322, 201-369-1500 Visit us: www.miamigrowersinc.com UPC 0893056003800 UPC 0893056003800 No lot code or expiration date Class III Pan Gilori contains Red dye, 45170-Rhodamine B-Basic Violet 10 and silver leaves and other metals at high levels. Miami Growers Inc.
Biologics Bone 00511066221031, 00511066221032, 00511066221033, 00511066221034, 00511066221035, 00511066221036, 00511066221037, 00511066221038, 00511066221039, 00511066221040, 00511066221041, 03511084751013, 03511084751014, 03511084751015, 03511084751017, 03511084751021, 03511084751022, 03511084751023, 03511084751024, 03511084751025, 03511084751026, 03511084751027, 03511084751028, 03511084751029, 03511084751030, 03511084751031, 04111071021051, 04111071021052, 04111071021053, 04111071021054, 04111071021055, 04111071021056, 04111071021057, 04111071021058, 04111071021059, 04111071021060, 04111071021062, 04111071021063, 04111071021064, 04111071021065, 04111071021066, 04111071021067, 00811006631015, 00811006631016, 0081106631017, 05711068421016, 05711068421015, 04312005041024, 04312005041025, 04312005041031,  ...
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Class II Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed. Musculoskeletal Transplant Foundation
Devices THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump. Lot Numbers 100/12/01, 116/12/01, 108/12/01, 109/12/01, 149/12/01 Class II The Spanish translation on the Instructions for Use (IFU) insert and product package for hot and cold packs has incorrect heating instructions which would cause product to over heat. Lansinoh Laboratories Inc
Veterinary Yoghund Organic Banana & Peanut Butter, Organic Frozen Yogurt for Dogs, 4-3.5 fl. oz. cups (4 pack), 14 fl. oz., (416 ml). Case: Lot Code: 26812 or earlier Cups: Best By Dates of 9.24.14 or earlier Class I Frozen dog treats recalled due to possible contamination with salmonella due to Sunland Peanut Butter recall TBD Brands
Drugs ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxidant Moisturizer Broad Spectrum SPF15, All Skin types, 1.7 FL. OZ. LIQ/50 ml (tube inside a unit carton) with UPC No. 2713179904, Code WKEM-01, and 1.5 mL foil sample packets, ESTEE LAUDER, DIST., NEW YORK, N.Y. 10022 NDC 11559-008-01 A70, A80, AA0, B11, A31, A51, B51, A81, A91, A12, A22, A72, BA0, AB0, BB0, CB0, AC0, BC0, A11, A21, B21, B31, A41. Class III Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stable over the shelf life, the sunscreen effectiveness may be less than labeled. Estee Lauder Inc
Devices Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. 61216907 61157229 00369603 61452214 00370029 00369698 61176450 00369643 00370031 61454835 00369732 00369699 61216908 61673516 61642322 62065259 61906448 61263152 61454836 61476896 00369630 61775736 61943339 61403525 61642325 61732773 61263539 61642324 61906449 62022702 62076908 61885843 61309789 61928501 61237709 61292681 61407876 61825843 61452216 61817457 61237707 61237708 61271325 61327754 61452215 61452217 61489313 61519975 61536413 61564182 61598285 61642323 00370315 00369632 61744558 61885845 62079957 61732772 61928502 61783457 61825844 61869694 61906453 62010604 61846487 61993146 61642326 61779030 61783460 61906450 62052790 61536692 61487482 61487481 61598295 61632192 61309790 61511677 61455839 61263540 61367254 61321073 61237710 61281183 61455840 00369649 61976102 61788120 61885847 61928503 61801103 61840614 61947562 61996712 61813950 61899040 61911390 62001304 61864069 61536693 61473713 61417315 62076907 61487483 61489314 61281184 61237711 61237712 61642328 61260584 61306613 61329094 61403527 61455843 61598296 61642327 00369605 61642329 61813945 61980779 61947563 62076909 61928504 61955589 61292682 62006523 61801104 61813948 61864070 61885848 61906451 61476897 61612715 61642330 61470887 61417316 61473724 61567576 61256570 61455841 61215903 61237713 61281185 61309791 61397913 61536694 00369645 61728663 61775735 61801102 61864071 61996713 61292684 61642332 61891249 61526509 61611815 61976103 61760310 61768196 61951207 62043439 61235829 61237714 61271326 61429593 61500680 61526508 61611819 61817458 62079956 61260587 61452212 61321074 61403528 61417317 61469130 61500681 61801101 61825845 61911391 62065258 61350519 00369738 00369635 61548179 61928505 61532294 61548180 61642333 61803766 61983681 62036846 61237716 61309792 61403529 61412049 61889258 61256571 61424318 61455846 61476898 62006522 00369803 61921682 61873604 61500682 61318326 61987182 61350520 00369741 00369702 00369639 61452213 00369640 61724206 00369705 Class II Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells. Zimmer, Inc.
Devices Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. 62245445 61633287 61709296 61633288 62252762 61843993 61992773 61761520 62215528 61398137 61338646 00115088 00115232 61403276 62167207 61371922 61807719 62005855 61330613 61490851 61514339 61761502 07892017 61268979 61278050 61278051 61338633 61354843 61384943 61622997 61693498 61730092 61780750 61831580 61581946 62109740 61227827 61645213 61461911 00113594 62252763 62016972 61930133 61236171 61499618 61693502 61926650 61962831 62049520 07892026 61268980 61330614 61371923 61398138 61449976 61490852 61581982 61603351 61629975 61639547 61748057 61772411 61801293 61831567 61851623 61366107 61278052 61278053 62084417 62185026 61227829 61338634 61658815 61476210 62245453 62056760 62030497 61761515 61236172 61366108 61403277 61566835 61596084 61813378 61860182 62011471 07892036 61203322 61268981 61278054 61278055 61281003 61338683 61360704 61371924 61419062 61449979 61490853 61581947 61622960 61633331 61737670 61784845 61831571 61962836 62180913 62078807 61227830 61645214 61476211 11000607 62011479 62042217 07891705 61603352 61278056 61338684 61366109 61769843 61831589 61973149 61236173 61268982 61278057 61278058 61333096 61371925 61514340 61633289 61791914 61813390 61860184 61946161 62084419 62245455 61429360 61645215 61227831 61384944 62270121 11000606 62049525 62005854 62159369 61680959 61851619 61596085 61792009 61236117 61268983 61278059 61278060 61338685 61366110 61371926 61639548 61819016 61398139 62011494 61670759 61950846 61603353 61278061 61419063 61490854 61761519 62126091 61843995 61622961 Class II Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells. Zimmer, Inc.
Devices Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. 61282267 61633887 61260645 61237937 61500763 61397941 61584769 61199849 61429445 61412089 00369745 Class II Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells. Zimmer, Inc.
Devices Trilogy Acetabular Shell Spiked. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. 00369642 00369648 00370032 00369656 61642334 00369644 61832805 61817455 61269936 61412631 61630564 00369407 61642337 61324694 61630563 61269937 61825837 61548181 61846490 61941029 61952408 61329095 61421263 61548182 61642336 60983133 61237717 61421264 00369660 61734272 62001310 61873606 61548185 61237808 61548184 61642338 60919315 61421260 61955590 61548186 61825841 61215919 61321081 61846488 61421258 61762005 61469142 61803767 61212922 61324695 61630550 61269940 61269941 61431735 61469143 61548190 61642339 61630567 61246475 61548191 61630565 61269943 61734270 60983134 61803771 61235835 61324696 61235836 61955591 61321084 61517446 61842609 61869695 00369695 61469149 61215920 61642341 61630551 61548201 61809017 61421267 61548199 61251222 61421266 61783461 61803769 61947736 61952415 61199836 61199839 61283453 61283454 61921683 00369661 61469151 61548205 61952422 61630552 61809012 61642342 61548206 61237809 61923871 61925091 61783462 61403530 61283455 61191067 00370048 00369663 61469152 61215929 61548212 61630569 61923872 61630553 00369638 61469154 00369651 00370752 61975586 00369664 11001720 61490760 62023765 61742082 61222252 61271664 61511137 61629985 61667049 61769838 61844002 61955479 61979981 61227814 61676615 61236278 61549718 61721127 61550409 62159365 61714399 11002260 62052850 07892033 61843998 61384952 61442061 61499614 61532992 61629982 61667062 61754419 61980115 61549720 61461917 61784734 62054500 61511139 61676596 61742071 61857680 61962840 62136223 61203311 62126090 61384953 61979983 07892046 61416489 61737672 61354833 61330560 61456504 62023767 61442060 61354834 07892052 61375761 61450049 62030472 61531423 61581705 Class II Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells. Zimmer, Inc.
Devices Trilogy Acetabular Shell with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. 00369733 00369629 61216911 61750773 61770610 61734420 61880355 61941709 61687733 61076227 61489318 61716316 61825784 62063923 61215851 61216909 61263156 61483182 61655830 61709193 61825783 61855188 61957104 61580848 61943340 62065253 62076915 61215855 61655829 61655831 61783469 61873616 61883392 61883393 61964702 61978754 61439036 61911394 62052806 61957102 61215850 61263155 61374949 61511679 61536418 61665446 61716314 61734423 61768199 61783470  ...
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Class II Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells. Zimmer, Inc.
Devices Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. Lot 61824006 61804625 61863921 61940938 61770118 61770119 61847292 62036280 62041700 62041701 62074562 61676075 61686843 61878991 62086541 07891486 61771223 61236214 61684940 61576456 61771214 61514324 62049465 61398128 61543099 61720987 61738788 61838669 61851627 61531431 61532988 61559753 61610337 61633328 61639533 61667050 61680958 61714507 61737663 61761440 61765336 61765339 61771213 61771215 61800650 61807684 61810992 61821391 61831558 61844005 61946147 61980002 61992760 62005870 62011425 62016937 62073253 62084392 61676078 61962791 62036281 61338624 61581713 61817237 61581712 61581714 61656292 61757712 61765340 61821393 61236215 61236216 61338666 61398129 61514325 61514326 61532990 61581711 61727955 61738789 61771216 61771221 61784813 61796131 61831565 61838671 61844006 61851628 61946319 61992761 61810993 61930116 62036282 61610338 61639534 61962792 61998856 62011426 61684942 61667051 62078581 61676591 61476225 61639535 62049467 61543101 61771224 61553782 61734089 62052856 61980006 61236218 61236219 61765337 61831549 62078789 61236217 61531433 61581715 61629973 61656293 61727956 61752676 61771217 61771218 61780740 61791906 61807685 61817238 61831566 61838672 61844007 61860174 62011427 62023771 62073255 61998857 61667052 61676081 61962793 61676592 61338667 61476226 61236220 61236223 61757711 61791907 61709237 61771219 61236224 61236222 61236225 61499616 61532989 61566825 61576457 61639536 61670754 61720991 61742089 61765341 61796132 61801296 61851630 61980010 61236221 61375787 61531434 61531435 61549723 61553783 61629974 61633329 61656294 61714520 61761441 61771220 61771225 61817239 61821392 61831602 61844008 61860172 62023772 61734088 61381468 61771222 61807695 62078790 61271672 61962794 61450095 61935498 62011428 61648309 61831560 61992762 61676593 61684943 61589940 61398130 62073158 62049468 62078791 61236226 61566826 61676594 62052858 61796133 61816923 61926630 61585972 61639537 61761437 61780739 61946148 61227823 61236227 61236228 61658812 61684944 61720985 61801295 61831554 61838670 61860173 61962795 61338627 62011408 61615428 61844009 62016940 61236229 61566827 61765338 61734090 61817240 61639538 61615429 61676614 61796134 77000185 77000183 61984086 61824007 61686847 77000184 07891300 61566829 61254413 61254414 61217880 62084422 61217883 61217882 61254415 62042220 61217884 61254416 61281004 61450096 61992779 61689279 61784742 61962845 61603391 61633330 61656295 61819023 61278095 61553784 61566830 61946162 61254417 62073243 61278096 61217885 61254418 61254419 Class II Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells. Zimmer, Inc.
Devices Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. 61567730 61558081 61611792 61559843 61567731 61611793 61215883 00369728 00369696 61930401 61459870 61611794 61564135 61201896 61292658 61783434 61915194 00369729 00369680 61921675 61638695 61915195 61906180 61808994 61425796 61580824 61471012 61263144 61201897 00369730 00370028 00370201 00370605 00370449 00369628 61996704 61779026 61533558 61758219 61455810 61452211 61911378 61596869 61734419 61783435 61794928 61201845 61783436 62055820 61580825  ...
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Class II Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells. Zimmer, Inc.
Devices Trilogy Acetabular AB Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. 62054788 61901417 61984072 61901423 61901426 61901427 61901428 61901435 61901437 61278096 Class II Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells. Zimmer, Inc.
Drugs Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-56. Lot #: Z021650AA, Exp. 08/2013 Class I Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals. Hospira Inc.
Drugs Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, NDC 61703-339-50 (Hospira label) and NDC 61703-360-50 (Novaplus label), Hospira, Inc., Lake Forest, IL 60045, Product of Australia. lots Z011711AA (Hospira label) and Z011711AB (Novaplus label), Exp. 08/2013 Class I Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals. Hospira Inc.
Devices Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, oxoid@thrmofisher.com (Both Remel & Oxoid, Ltd are a part of Thermo Fisher Scientific) An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure, by a disc-agar diffusion technique or a disc-broth elution technique, the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents (Aztreonam). Lot 1100699 Class II The firm is recalling the product due to some cartridges may contain individual discs that are not impregnated with antibiotic. The firm notified their customers of the recall with a notification letter and requested a confirmation fax back of receipt. Remel Inc
Devices PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion. Model 5400. Serial numbers: 540100017, 540100020, 540100063, 540100160, 540100161, 540100162, 540100062, 540100103, 540100104, 540100105, and 540100106. Class II The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states. Winco Mfg., LLC
Devices PREMIER CARE RECLINER 5570/5574 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion. Model 5570 and 5574. Serial numbers: 557A100080, 557A100081, 557100004, 557100008, 557100009, 557100012, 557100041, 557100042, 557100043, 557100044, 557100045, 557A100065, 557100036, 557100037, 557100038, 557100039, 557A100073, and 557100048. Class II The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states. Winco Mfg., LLC
Devices Cozy Comfort Premier Recliner 5580 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion. Model 5580. Serial numbers: 558A100057, 558100022, 558100023, 558100024, 558100025, 558100026, and 558A100075. Class II The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states. Winco Mfg., LLC
Devices Designer Care Cliner 6700/6704/6710 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion. Model 6700, 6704 and 6710. Serial numbers: 670A100027, 670A100028, 670A100323, 670100082, 670100083, 670A100101, 670A100021, 670A100324, 670A100325, 670A100284, 670A100242, 670100005, 670100124, 670100125, 670100181, 670100182, 670100183, 670100184, 670100185, 670100186, 670100026, 670A100004, 670A100036, 670A100037, 670A100038, 670A100039, 670A100040, 670A100041, 670A100042, 670A100043, 670A100044, 670A100124, 670A100135, 670A100138, 670A100137, 670A100278, 670A100299, 670A100308, 670A100345, 670A100365, 670A100191, 670A100243, 670A100303,  ...
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Class II The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states. Winco Mfg., LLC
Biologics Blood and Blood Products for Reprocessing W036512022332; Class III Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. LifeShare Blood Centers
Biologics Platelets Pheresis Leukocytes Reduced 22KW06774; Class II Blood product, which did not meet the acceptable product specifications, was distributed. American National Red Cross, Penn-Jersey Region
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W036809232318A; W036809232318B; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036812847654; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036812401405; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced Irradiated W036812831776; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma W036812401405; W036811297334; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Plasma Frozen within 24 hours (FP24) W036812499106; W036812505250; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Fresh Frozen Plasma W036812436897; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Blood and Blood Products for Reprocessing 06GT81779; Class III Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. American National Red Cross The
Biologics Red Blood Cells Leukocytes Reduced W043211073742; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Blood and Blood Products for Reprocessing W043211073742; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Plasma Frozen Cryoprecipitated Reduced W043212029454; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Cryoprecipitated AHF, Pooled W043212029454; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Red Blood Cells Leukocytes Reduced W043212029454; W043211086744; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Blood and Blood Products for Reprocessing W043211086744; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Red Blood Cells Leukocytes Reduced W043211076210; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Blood and Blood Products for Reprocessing W043211076210; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics VistA Blood Establishment Computer Software (VBECS) ALL Versions of VistA Blood Establishment Computer Software (VBECS) Class II Software, with a defect or glitch, was distributed. Dept Of Veterans Affairs Office Of Information & Technology
Biologics Capture-P Indicator Red Cells, 1 x 11.5mL Lot Nos. 226183, 226184, 226185 Class III Capture-P Indicator Red Cells, with confirmed weaker than expected reactivity with the weak positive control, were distributed. Immucor Inc
Drugs Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 0270-1316-67), 10 x 125 mL (NDC 0270-1316-68) Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany). Lot #: 9K37791, Exp 11/12; 9L40746, Exp 12/12; 0A43705, Exp 01/13; 0C57509, 0C57521, Exp 03/13; 0E62913, Exp 05/13 Class I Presence of Particulate Matter; fibers identified as cellulose and polyvinyl Bracco Diagnostic Inc
Drugs Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany); NDC 0270-1315-67. Lot #: 9K34572, Exp 11/12; 0A43282, Exp 01/13; 0C56283, Exp 03/13 Class I Presence of Particulate Matter; fibers identified as cellulose and polyvinyl Bracco Diagnostic Inc
Devices Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures. Lot number: 2000930 Class II Contact between the bur and bur guard could generate metal fragments that may or may not be visible to the surgeon and can potentially remain in the surgical site. The materials used to fabricate the bur guard are not traceable, design validation did not effectively evaluate adequate protection of adjacent tissue and inspection results for each of these bur guards were not documented. The Anspach Effort, Inc.
Biologics Blood Bank Control System (BBCS) Primary Application 5.0 - software for device. BBCS Primary Application 5.3.4, 5.3.5, 5.3.6, 5.3.7, 5.3.8, 5.4.0 and 5.4.0.1 Class III Blood Bank software, with a defect or glitch, was distributed. Blood Bank Computer Systems, Inc
Biologics Blood Bank Computer Systems (BBCS) Primary Application 5.0 - device software BBCS Primary Application 5.0, 5.1, 5.2, 5.2.1, 5.2.2, 5.3.0, 5.3.1, 5.3.2, 5.3.3, 5.3.4, 5.3.5, 5.3.6, 5.3.7, 5.3.8, 5.4.0 and 5.4.0.1 Class II Blood Bank software, with a defect or glitch possibly causing mislabeling blood products with a donor's CMV status, was distributed. Blood Bank Computer Systems, Inc
Food Canned mandarin oranges labeled in part: "WESTERN FAMILY Choice Selections Mandarin Oranges Naturally Sweet in Mandarin Orange Juice NET WT 10.5OZ (297g)***Ingredients: Mandarin Oranges, Mandarin Orange Juice. Proudly Distributed by Western Family P.O. Box 4057, Portland, OR 97208 U.S.A.***Product of China***0 15400 01241 6***" Can Code: S8 4500/01068 601 ORJ Best By Dates: NOV 14, 2014; DEC 14, 2014; DEC 15, 2014 and JAN 31, 2015 Case UPC: 100 15400 01241 3 Can UPC: 0 15400 01241 6 Class III The firm received two consumer complaints regarding chemical smell/taste and tasting like the can. As a result the firm began extensive testing of its inventory. Preliminary testing identified a contaminant was present. Further testing is pending to specifically identify the contaminant. Acme Food Sales, Inc
Devices ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch Lot 256058 Class II ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm. Linvatec Corp. dba ConMed Linvatec
Biologics Ortho Pipetter Volume Verification Kit Ortho Clinical Diagnostics a Johnson & Johnson Company 1001 US Highway 202, Raritan, NJ 08869 USA 1-800-421-3311 Product Code 937924 Product Code 937924; Lot Number 0007 Class III Ortho Pipetter Volume Verification Kit, Lot 0007, mislabeled with the incorrect expiration date, was distributed. Ortho Clinical Diagnostics Inc
Biologics Blood Grouping Reagent, Anti-e (Human Monoclonal)(IgM)(For Further Manufacturing Use) EMD Millipore Catalog Number: WD-1L-BK EMD Millipore Lot Number: WDB1101 Class III Single lot of Blood Grouping Reagent For Further Manufacturing Use, with a stability test point failure, was distributed. Millipore (UK) Ltd.
Biologics Labeled in part: ***Meningococcal***Groups A, C, Y and W-135***Oligosaccharide***Diphtheria***CRM***197***Conjugate***Vaccine***Menveo(R)***Powder and solvent for injection***NDC 46028-208-01***Rx Only***NOVARTIS***vaccines***Store refrigerated, away from the freezer compartment, at 36 degrees F to 46 degrees F (2 degrees C to 8 degrees C), protect from light***for intramuscular injection, read the package leaflet before use*** PSSWM Item Number 238361 Lot #M10135B Exp 2/18/2013 Class III Meningococcal Oligosaccharide Diphtheria Conjugate Vaccine, with lack of assurance of proper temperature maintenance during shipment, was distributed. PSS World Medical Shared Services
Veterinary WSI Pride Plus Amprolium Crumble 1.25%, packaged in a 50 lb. bag. The Product code/number is 104636. Tag is tan in color; with the lot number and product number located at the bottom of the tag just above the tag sew line. The product is labeled in parts: "***WSI Pride Plus Amprolium Crumble 1.25%***For Beef and Dairy Calves***MEDICATED An aid in the prevention and treatment of coccidiosis caused by Eimeria bovis and E. zurnii in calves***ACTIVE DRUG INGREDIENT***Amprolium (Corid) 1.25%***MANUFACTURED BY WESTERN STOCKMEN'S, CALDWELL, ID 83605*** 208-459-0777***". Lot No. 340209114-090712 The lot number consists of the first 9 digits, i.e., 340209114 and is a unique identifier. The Product code is the unique code assigned in the firm's database for this named finished feed product. The number 090712 is September 7, 2012. The tag was made on Sept. 7.  ...
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Class II WSI Pride-Plus Amprolium Crumble 1.25% was found to be sub-potent for Amprolium. The sample was detected of 0.9758% instead of 1.25% concentration of Amprolium. Western Stockmen's
Drugs Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl. oz. (15 mL) spray bottle, Developed and distributed by Zicam LLC, Scottsdale, Arizona 85255, a wholly owned subsidiary of Matrixx Initiatives Inc, NDC 62750-005-10, UPC 7 32216 20410 0. Lot # 2J23, Exp 09/15 Class I Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia. Matrixx Initiatives Inc
Biologics Standardized Mite Allergenic Extract E1204385 Class III Standardized Mite Allergenic Extract, mislabeled with the incorrect strength, was distributed. Jubilant HollisterStier, LLC
Drugs PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1473-01), b) 1000-count tablets per bottle (NDC 0143-1473-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724. Lot #: 69403A, 69403B, Exp 10/15; 69404A, 69405A, 69515A, 69702A, 69702B, 69703A, Exp 11/15; 69767A, 69767B, Exp 12/15 Class II Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets. West-ward Pharmaceutical Corp.
Biologics Blood and Blood Products for Reprocessing 019LJ61879 Class III Bloood product, collected from an ineligible donor, was distributed. American Red Cross Blood Services Tennessee Valley Region
Biologics Cornea CN100823OD Class II Human Cornea, recovered in a manner that increased the risk of the introduction, transmission, or spread of communicable disease, was distributed. Indiana Lions Eye and Tissue Transplant Bank
Devices Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement. Catalog No. 130-3253, Serial Numbers 2479944 - 2479969 and Catalog No. 136-32-53, Serial Numbers 2479873 - 2479898. Class II Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed. Exactech, Inc.
Devices Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement. Catalog No. 130-3253, Serial Numbers 2479944 - 2479969 and Catalog No. 136-32-53, Serial Numbers 2479873 - 2479898. Class II Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed. Exactech, Inc.
Devices Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position. Model #3G, Serial numbers: 12GE003750, 12GE003554 and 12HE001766. Class II The potential exists for the wheel to rotate freely despite engagement of hub brake. Invacare Corporation
Food Mama Tere Cebada Natural Barley Flour Net Weight /Peso Neto: 12 oz (340g) Family Food Distributors Bergen Avenue Kearny, NY 07032 UPC 7412003000259 n/a Class III Mama Tere Cebada Flour contains undeclared colors Red #3 and Red #40. Family Food Distributor, Inc.
Drugs Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules per bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, Distributed by: Watson Pharma, NDC 62037-700-90. Lot #: 512146A, Exp 01/31/2014 Class II Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time point was 41% (specification: 20-40%). Watson Pharmaceuticals
Devices Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases. part number RS-00402 Unit ID # (TS-): 001418, 001419, 001420, 001421, 001422, 001423, 001424, 001425, 001426, 001427, 001428, 001429, 001430, 001431, 001432, 001433, 001434, 001435, 001436, 001437, 001438, 001439, 001440, 001441, 001442, 001443, 001444, 001445, 001446, 001447, 001448, 001449, 001450, 001451, 001452, 001453, 001454, 001455, 001456, 001457, 001458, 001459, 001460, 001461,  ...
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Class II Due to past battery inventory storage conditions and deficiencies in the maintenance procedure, it was possible that some batteries were over-discharged to point of damaging the cells. Oxus America, Inc.
Devices SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures. Lot Numbers: P2012040901 (US) P2011080101B and P2011090901A (Outside the US) Class II Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured Allergen Medical
Devices Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy. LOT NO. 100212 EXPIRES: 06/2013 Class II Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter. Custom Healthcare Systems, Inc.
Devices Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy. LOT NO. 60812 EXPIRES: 11 /2012 Class II Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter. Custom Healthcare Systems, Inc.
Devices P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii P10 Device. MyTobii P10 is a portable eye-controlled communication device featuring the Tobii Eye Control system. Product Code 510410, all units. Class II Tobii ATI customers P10 external battery pack, which contains sealed lead-acid batteries, malfunctioned while recharging and produced smoke with a chemical smell. Tobii Assistive Technology, Inc.
Drugs Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05) and b) 1000-count tablets per bottle (NDC 0143-1176-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724. Lot #: 69364A, 69365A, and 69365B, Exp 10/15 Class II Presence of Foreign Substance: Uncharacteristic blacks spots on tablets. West-ward Pharmaceutical Corp.
Devices Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus from patient specimens. Model #:49-0600, Lot#, 491206T, 491216; Model #: 49-0600A, Lot#, -A-491206T, -A-491216, -A-491216B; Model #: 49-0102A, Lot#, -A-491206T, -A-491216 & Model #: 49-T075A, Lot#, -A-491206T, -A-491216. Class III Fungal contamination. Diagnostic Hybrids Inc
Drugs EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump depression, for use as physician starter samples; product is labeled in part ***Manufactured for ASCEND Therapeutics Herndon, VA 20170 by DPT Laboratories San Antonio TX 78215*** Lot Number: EHAD Exp. 07/14 Class III Defective Container: Pump head detaching from the canister unit upon removal of the overcap. Ascend Therapeutics Inc
Drugs Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral contraceptive tablet, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ LF01215A, Exp 02/2014 Class III Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3. Sandoz Incorporated
Devices Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications Serial Numbers 362600, 362601, 364209, 364210, 375245, 375850, 376439, 384396, 387492, 398185, 399440, 399621, 399623, 402409 Class II The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system. Philips Healthcare Inc.
Devices OPTIGEN Food 30; Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France Allergen testing Catalog number: 85035. Lot number 42K283626, expiration May 31, 2013. Class III A non conformance was identified with one lot of OPTI GEN Food 30 where there is no evidence that a visual inspection was performed on one tray of coverslips, Hitachi Chemical Diagnostics Inc
Devices KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography Lot 2114596 (Exp. September 2014) Class III Missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The Manufacturer symbol, name and address including country of origin are missing. All of the remaining symbols and information are on the case label. Missing information is only associated with the clear carton label. Carestream Health, Inc.
Food Annie's Homegrown Rising Crust Four Cheese Pizza. Mozzarella, Provolone, Parmesan and Romano Cheese. Certified Organic, 23.5 oz package. Product UPC: 0 13562-20001 6; Case UPC 1 00 13562 20001 3 Annie's, Inc. 1610 5th Street Berkeley, CA 94710 All product with best by dates between 09 Jan 2013 and 14 Sep 2013. Class II Annie's Homegrown was notified by their flour supplier that due to a faulty screen at the flour mill, there is the possibility of metal fragments in some of their pizza products. The USDA was also notified as some of the products fall under their jurisdiction. Annie's Homegrown Inc
Food Annie's Homegrown Rising Crust Spinach and Mushroom Pizza. Spinach, Portobello and Button mushrooms with a Garlic Parmesan cream sauce.. Certified Organic, 25.0 oz package. Product UPC: 0 13562-20005 4; Case UPC 1 00 13562 20005 1 Annie's, Inc. 1610 5th Street Berkeley, CA 94710 All product with best by dates between 09 Jan 2013 and 14 Sep 2013. Class II Annie's Homegrown was notified by their flour supplier that due to a faulty screen at the flour mill, there is the possibility of metal fragments in some of their pizza products. The USDA was also notified as some of the products fall under their jurisdiction. Annie's Homegrown Inc
Food Annie's Homegrown Rising Crust Four Cheese Pizza. Mozzarella, Provolone, Parmesan and Romano Cheese. 22.5 oz package. Product UPC: 0 13562-20007 8; Case UPC 1 00 13561 20007 5. Annie's, Inc. 1610 5th Street Berkeley, CA 94710 All product with best by dates between 09 Jan 2013 and 14 Sep 2013. Class II Annie's Homegrown was notified by their flour supplier that due to a faulty screen at the flour mill, there is the possibility of metal fragments in some of their pizza products. The USDA was also notified as some of the products fall under their jurisdiction. Annie's Homegrown Inc
Drugs Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceuticals US, Inc, 5000 Shoreline Court, Ste 200, South San Francisco, CA 94080, NDC: 66215-302-30. Lot #: MA00AD5, Exp: 11/30/2014 Class III Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point. Actelion Pharmaceuticals U.S., Inc.
Food MET-Rx EXTREME THERMO RAGE WATERMELON DIETARY SUPPLEMENT, 8 FL. OZ. (240 mL) , Product Number 50390 (Bulk number 50389), UPC 7 86560 50389 1, Label Revision 00B --- Manufactured in the USA by MET-RX Nutrition, Inc. Boca Raton, FL 33487 Lot # 430855, Expiration Date 12/21/12; Lot # 430856, Expiration Date 12/29/12 Class III Acetobacter lovaniensis was detected in a sample of the product tested by a private laboratory. This is an issue of commercial spoilage. NBTY Inc.
Food PURE PROTEIN PROTEIN SHOT 25g PROTEIN, GRAPE Flavor PROTEIN DRINK 2.9 fl. oz. (86 mL), Product Number 50451, Bulk Number 36753 (Vial), UPC 7 49826 50451 3 (Vial), and Product Number 50452, Bulk Number 36753 (Carton of 6), UPC 7 49826 50452 0 (Carton). --- Carefully Manufactured by Worldwide Sport Nutritional Supplements, Inc. Bayport, NY 11705 Lot # 406844, Expiration Date 04/03/2013; Lot # 439941, Expiration Date 07/26/2013; Lot # 445206, Expiration Date 10/31/2013; Lot # 456438, Expiration Date 11/30/2013 Class III Lactobacillus plantarum and Lactobacillus brevis were detected in a sample of the product tested by a private laboratory. This is an issue of commercial spoilage. NBTY Inc.
Devices Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery. Lot/Unit Codes: 075023, 075064, 084000, 084001, 084326, 084743, 084815, 085202, 085455 Class II The tip of the Quadra Trial Broach size 0, broke during a surgery. Medacta Usa Inc
Devices Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; LSX Files, 30MM, Part Numbers: 835-2031. An engine-driven rotary endodontic instrument used during endodontic procedures for cleaning and shaping the root canal. Part # 835-2525, Lot # 091274189. Part # 835-2455, Lot # 091272054, 091279295, 101200609, 101200610, 101200612. Part # 835-2031, Lot # 091268204. Class II The length markings on the Lightspeed LSX files were wrong. Ormco/Sybronendo
Food Dried Preserved Plum packaged in clear 4.4 lb (1904 g) plastic packages. The product comes in bulk form in a brown corrugated box with 10 x 4.4 lb packages. Net weight of one case is 44 lbs.. Product information is provided on the case with product name "Dried Preserved Plum" and Net Weight 44 lbs. (Product was destroyed and photos of product are not available). Distributed by Nuera Trading Company Inc., San Leandro, CA. Manufactured by Zi Jing Yuk Hin Enterprises, Guangdong, China. No code information Class II California Department of Public Health sampled Dried Plum Preserves in 4.4 lb packages and found it to contain lead at 1.5 and 1.6 ug/g. Nuera Trading Company Incorporated
Drugs Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India, NDC 0378-8030-05. Lot #: 1110829, Exp 05/14 Class II Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets. Mylan Pharmaceuticals Inc.
Drugs Methocarbamol 750 mg Tablets, 90-count bottle, Mfg by: West-Ward Pharm. Corp., Eatontown, NJ 07724, Packaged and Distributed by: Stat Rx USA, NDC 42549-521-90. A02568, Exp 01/16 Class III Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled with an expiration date of 10/16 instead of 01/16. Stat Rx USA
Food Vietnamese Cinnamon Extra Fancy, product code 43200, Penzeys Spices, Wauwatosa, WI 53222. to be completed 1454800 Class II Penzeys received a complaint from a customer who found pieces of glass in bulk Vietnamese Cinnamon. Penzeys LTD
Food Imperial Nuts and Snacks Chocolate and Peanut Platter. Packed By: Star Snacks CO., LLC, Jersey City, NJ 07305. Net Wt. 26 oz (737 g) UPC 5351946762. Lots 20I272 and 19I276. Class II Imperial Nuts & Snacks brand of Chocolate and Peanut Platter (Net Weight 26 ounces) has undeclared FD&C colors Blue #1, Red #40, Yellow #5 and Yellow #6. Star Snacks Co., Llc.
Food Outer Cardboard Container - China Products Fresh Dried Cabbage. Plastic Bag: Double Swallow Brand, Net Wt 0.15 Kg (529 OZ), Dehydrated Cole, Jiangmen Native Produce Import & Export Company of Guangdong China. All codes. Class II The product contains undeclared sulfites (as a preservative). Tristar Food Wholesale Co Inc
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