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U.S. Department of Health and Human Services

Enforcement Report - Week of August 22, 2012

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Event Detail

Event ID 62416
Product Type Drugs
Status Ongoing
Recalling Firm Franck's Lab Inc., d.b.a. Franck's Compounding Lab
City Ocala
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-25
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
HYDROMORPHONE/CLONIDINE P. F. 120MG/1.3MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE P. F. 120MG/1.8MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE P. F. 80MG/1.2MCG/ML INTRATHECAL 10 ML (3 DIFFERENT PRODUCTS) Rx #'s:N0395798 N0397394 N0392201 N0400799 N0403781 N0407180 N0390189 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 7 units D-1542-2012
HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1500MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% SODIUM CHLORIDE) 50MG/500MCG/7.5MG/ML I 18 ML (3 DIFFEENT PRODUCTS) Rx #'s:N0391871 N0395248 N0400014 N0404731 N0404936 N0408940 N0387888 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 7 units D-1541-2012
HYDROMORPHONE P.F. 20MG/ML INTRATHECAL 40 ML; HYDROMORPHONE P.F. 25MG/ML INTRATHECAL 18 ML; HYDROMORPHONE P.F. 30MG/ML INTRATHECAL 18 ML; HYDROMORPHONE P.F. 50MG/ML INTRATHECAL 40 ML (4 DIFFERENT PRODUCTS) Rx #'s:N0393645 N0399634 N0398233 N0388437 N0395176 N0396644 N0403778 N0396442 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 8 units D-1540-2012
HYDROGEN PEROXIDE PF 3% INJECTABLE 150 ML, 200 ML, 50 ML, 60 ML (4 DIFFERENT PRODUCTS) Rx #'s: 0401261 0371940 0396624 0401261 0402167 0387248 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 8 units D-1539-2012
HYDROCHLORIC ACID INJECTION 2MG/ML INJECTABLE 400 ML, 60 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0389733 0398961 0398282 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 6 units D-1538-2012
HYALURONIDASE/METHYLPREDNISOLONE ACETATE, P.F. 37.5U/20MG/ML INJECTABLE 20 ML (1 PRODUCT) Rx #: 0383354 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 4 units D-1537-2012
HYALURONIDASE / LIDOCAINE / BUPICAVAINE 7.1U/9.5MG/3.5MG/ML INJECTABLE 210 ML, 525 ML, 630 ML; HYALURONIDASE/LIDOCAINE/EPI/BUPIVICAINE INJECTABLE 32 ML, 64 ML (5 DIFFERENT PRODUCTS) Rx #'s: 0359947 0408187 0359947 0389777 0389777 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 9 units D-1536-2012
HYALURONIDASE / LIDOCAINE 7.1U/9.5MG/ML INJECTABLE 105 ML, 210 ML (6 DIFFERENT PRODUCTS) Rx #'s: 0359944 0359944 0408186 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 17 units D-1535-2012
HYALURONIDASE - PRESERVATIVE FREE 150 U/ML INJECTABLE 1 MLS, 10 MLS, 100 MLS, 12 MLS, 12.5 ML, 120 MLS, 15 MLS, 16 ML, 16 MLS, 2 MLS, 20 ML, 20 MLS, 24 MLS, 25 ML, 30 ML, 30 MLS, 36 MLS, 4 MLS, 40 MLS, 44 ML, 5 MLS, 50 ML, 50 MLS, 6 ML, 6 MLS, 60 MLS, 8 MLS, 80 MLS, 9 ML; HYALURONIDASE - PRESERVATIVE FREE 200 U/ML INJECTABLE 2 MLS; HYALURONIDASE / LIDOCAINE / BUPICAVAINE 7.1U/9.5MG/3.5MG/ML INJECTABLE 210 ML, 525 ML, 630 ML; HYALURONIDASE / LIDOCAINE 7.1U/9.5MG/ML INJECTABLE 105 ML, 210 ML; HYALURONIDASE 150 U/ML INJECTABLE 0.2 MLS, 0.3 MLS, 0.8 MLS, 1 MLS, 10 MLS, 12 MLS, 15 MLS, 20 MLS, 25 MLS, 3 ML, 4 ML, 40 MLS, 5 MLS, 50 MLS, 60 MLS, 8 MLS, 80 MLS; HYALURONIDASE NO PRES 100 U/ML INJECTABLE 24 MLS, 40 MLS (48 DIFFERENT PRODUCTS) Rx #'s: 0366959 0388654 0388657 0388658 0388660 0388661 0388662 0388664 0388665 0388667 0388669 0388670 0388672 0388673 0390311 0390330 0390334 0390337 0390340 0390343 0390346 0390348 0390355 0390357 0390359 0390362 0391423 0391429 0391430 0391432 0391438 0391439 0391442 0391448 0391449 0391450 0391453 0391455 0391456 0391458 0391462 0391465 0391467 0391470 0395839 0395841 0395843 0395846 0395850 0395852 0395865 0395867 0395868 0395873 0395874 0395875 0397179 0397189 0397193 0397195 0397203 0397205 0397209 0397210 0397213 0397214 0397216 0397218 0397220 0397223 0397226 0397228 0397229 0399091 0399093 0399097 0399098 0399102 0399140 0399141 0399142 0399147 0399151 0399154 0399843 0399847 0399849 0399850 0399853 0399858 0399859 0399863 0399866 0399870 0399872 0399873 0399877 0399879 0399880 0399881 0402800 0402801 0402802 0402805 0402806 0402808 0402811 0402813 0402815 0402816 0402817 0402818 0402819 0402820 0402821 0402822 0402824 0404680 0404683 0404684 0404686 0404687 0404689 0404690 0404691 0404692 0404693 0404695 0404698 0404701 0404704 0405948 0405949 0405951 0405954 0405955 0405958 0405959 0405963 0405964 0405965 0405967 0405969 0406682 0406685 0406688 0406690 0406691 0406695 0406698 0406702 0406703 0406705 0406709 0406713 0406716 0406719 0406721 0406727 0409290 0409291 0409294 0409297 0409299 0409304 0409305 0409306 0409307 0409308 0409310 0409312 0409313 0409315 0409689 0409691 0409695 0409698 0409699 0409715 0409717 0409718 0409721 0409723 0409729 0409733 0363730 0369336 0382310 0387728 0389871 0394063 0357268 0366414 0398896 0367820 0387644 0370181 0387728 0397783 0367820 0394280 0366959 0397783 0400745 0366414 0387644 0397783 0397783 0369339 0387728 0367820 0382310 0352468 0394551 0406837 0397783 0386976 0398395 0358143 0397783 0372798 0385858 0397783 0367820 0386976 0398032 0385858 0367820 0382402 0395305 0384431 0387955 0397783 0392988 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 326 units D-1534-2012
HYALURONIC ACID SODIUM SALT 10MG/ML INJECTABLE 100 ML, 20 ML; HYALURONIC ACID SODIUM SALT, P.F. 20MG/ML INJECTABLE 500 ML (3 DIFFERENT PRODUCTS) Rx #'s: 0399566 0389886 0407257 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 3 units D-1533-2012
GLYCERIN 99.5% OPHTHALMIC 10 ML, 5 ML, 7.5 ML; GLYCERIN 100% OPHTHALMIC 15 ML (4 DIFFERENT PRODUCTS) Rx #'s: 0405776 0405779 0393390 0405545 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 4 units D-1530-2012
BIMIX 30MG / 4MG INJECTABLE 10 ML, 5 ML; BIMIX 30MG / 5MG INJECTABLE 10 ML; BIMIX 9MG / 0.25MG INJECTABLE 10 ML, 5 ML; BIMIX 15MG / 1MG INJECTABLE 10 ML; BIMIX 18MG / 0.5MG INJECTABLE 10 ML, 5 ML; BIMIX 18MG / 1MG INJECTABLE 5 ML; BIMIX 20MG / 0.75MG INJECTABLE 5 ML; BIMIX 26MG/1MG/ML INJECTABLE 10 ML; BIMIX 26MG/2MG/ML INJECTABLE 20 ML; BIMIX 30MG / 0.5MG INJECTABLE 10 ML, 20 ML,5 ML, 50 ML, 60 ML; BIMIX 30MG / 1.5MG INJECTABLE 5 ML; BIMIX 30MG/1MG INJECTABLE 1 ML, 10 ML, 10 MLS, 12 ML, 150 ML, 2 ML, 20 ML, 20 MLS, 3 ML, 30 ML, 40 ML, 5 ML, 5 MLS, 50 ML, 6 ML, 60 ML, 7 ML; BIMIX 9MG / 0.5MG/ML INJECTABLE 5 ML; BIMIX 15MG / 0.5MG INJECTABLE 10 ML, 5 ML; BIMIX 16.6MG / 0.55MG/ML INJECTABLE 10 ML, 4.5 ML; BIMIX 30MG / 2MG INJECTABLE 10 ML, 5 ML; BIMIX 30MG/3MG/ML INJECTABLE 10 ML, 5 ML; BIMIX 40MG/2MG INJECTABLE 10 ML, 3 ML, 6 ML; BIMIX 40MG/3MG INJECTABLE 3 ML; BIMIX, SDSM 9MG / 0.25MG INJECTABLE 10 ML; BIMIX, SDSM 9MG / 0.5MG INJECTABLE 10 ML; BIMIX, SDSM 18MG / 0.5MG INJECTABLE 10 ML, 10 MLS; BIMIX, SDSM 30MG / 1.5MG INJECTABLE 10 ML, 10 MLS, 5 ML, 5 MLS; BIMIX, SDSM 30MG / 1MG INJECTABLE 10 ML, 5 ML (58 DIFFERENT PRODUCTS) Rx #'s: 0384355, 0389246, 0392332, 0399800, 0407377, 0385460, 0389158, 0402762, 0385460, 0359057, 0385462, 0396242, 0385462, 0391321, 0372399, 0400437, 388360, 0350745, 0354900, 0357950, 0365803, 0391686, 0393285, 0393620, 0395404, 0399228, 0399302, 0401675, 0401844, 0403731, 0406162, 0408427, 0409073, 0399228, 0371562, 0376422, 0396380, 0405576, 0405582, 0405586, 0384289, 0366702, 0360431, 0408278, 0390548, 0396007, 0401479, 0352078, 0352368, 0354526, 0354595, 0357480, 0358685, 0359207, 0363768, 0364549, 0368498, 0369212 0373766 0374428 0375279 0375571 0375873 0377397 0380000 0380005 0381659 0382914 0384657 0386665 0387419 0387519 0387699 0388026 0388292 0388330 0388766 0389900 0390082 0390315 0391607 0392449 0392525 0392848 0393087 0393381 0393499 0393828 0393904 0394395 0394985 0395878 0395912 0396010 0396019 0396120 0396163 0396207 0396267 0396366 0396906 0397063 0397523 0397527 0397728 0398291 0398862 0399237 0399251 0399644 0399898 0401001 0401380 0401414 0401480 0401858 0401991 0402382 0402634 0403182 0403417 0404396 0404958 0404962 0404965 0405377 0405697 0406246 0406753 0406809 0407466 0407512 0407521 0407830 0408706 0408768 0408828 0409007 0409150 0409158 0409809 0388728 0409113 0395179 0401812 0380005 0390728 0408848 0357188 0380005 0388326 0388531 0398590 0407315 0359319 0379979 0380005 0398376 0406549 0390081 0390728 0406512 0350594 0351237 0354526 0358579 0358794 0361059 0362431 0363752 0367108 0367355 0368710 0369213 0369806 0369811 0370264 0370618 0373793 0375571 0378322 0378326 0378513 0378942 0379218 0379983 0380003 0380005 0380149 0382749 0383556 0386269 0386665 0387095 0387179 0387861 0388633 0388634 0388636 0388637 0388638 0388641 0388894 0389374 0389385 0389548 0389790 0390777 0390779 0390781 0390782 0390784 0390790 0392100 0392378 0392380 0392388 0392390 0392508 0392649 0393106 0393111 0393112 0393114 0393115 0393117 0393118 0393836 0393838 0393839 0393841 0393843 0393846 0393848 0394141 0394181 0395615 0395620 0395622 0395623 0395625 0395628 0395632 0395635 0395636 0395921 0396045 0396534 0397327 0397406 0397473 0397475 0397476 0398304 0398372 0399460 0399467 0399469 0399471 0399476 0399478 0399481 0399841 0400028 0400032 0400169 0400782 0400791 0401362 0401477 0402466 0402681 0402687 0402699 0402709 0402711 0402713 0402715 0403292 0403743 0404300 0404953 0405053 0405058 0405061 0405264 0405284 0405391 0405392 0405394 0405850 0405855 0405863 0405866 0406896 0407031 0407430 0407614 0407619 0407623 0407625 0407626 0407631 0407708 0407758 0407835 0407845 0408266 0408719 0408839 0409260 0409369 0409644 0409663 0409666 0409667 0409672 0409676 0409685 0409803 0409810 0409811 0409984 0410385 0376121 0388330 0398376 0402184 0354526 0380005 0384306 0402150 0380005 0395412 0351617 0377040 0405279 0351625 0398027 0400613 0405073 0356174 0366355 0366652 0372365 0377239 0377604 0384197 0384239 0388883 0389914 0390003 0392798 0393394 0393804 0396191 0396863 0398155 0400682 0401354 0402361 0402772 0406281 0407525 0408139 0408807 0366728 0395638 0392966 0402974 0405261 0397156 0390549 0405381 0359548 0381259 0390539 0396023 0405381 0359548 0405381 0388337 0391331 0395269 0408053 0392770 0360349 0382004 0394651 0404245 0406333 0397786 0394838 0389554 0395413 0397465 0395413 0395411 0395411 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 448 units D-1466-2012
GLUTATHIONE INHALATION 30MG/ML SOLUTION 120 ML, 60 ML; GLUTATHIONE P.F. 200MG/ML INJECTABLE 10 ML, 100 ML, 14 ML, 150 ML, 175 ML, 20 ML, 30 ML, 300 ML, 40 ML, 40 MLS, 50 ML, 58 MLS, 70 ML; GLUTATHIONE P.F. 50MG/ML (500MG/10ML) INJECTABLE 100 ML, 150 ML, 20 ML, 40 ML, 60 ML; GLUTATHIONE-FFC 100MG/ML INJECTABLE 20 ML (21 DIFFERENT PRODUCTS) Rx #'s: 0389833 0394741 0392912 0388244 0397159 0399176 0388244 0405177 0409379 0392912 0397159 0377235 0408837 0402247 0388244 0397159 0403342 0404418 0388244 0393276 0393276 0351537 0393276 0351537 0393276 0390499 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 47 units D-1529-2012
GENTAMICIN 40MG/ML (80MG/2ML) INJECTABLE 20 ML, 40 ML, 48 ML, 50 ML; GENTAMICIN / SODIUM BICARBONATE (STERILE) 480MG/LITER SOLUTION 1000 ML; GENTAMICIN /CLINDAMYCIN /POLYMIXIN B/STERILE WATER 0.1%/0.1%/0.05% SOLUTION 250 ML, 500 ML; GENTAMICIN DROPS (FORTIFIED) 14MG/ML (1.4%) OPHTHALMIC 10 ML; GENTAMICIN DROPS (FORTIFIED) 15MG/ML (1.5%) OPHTHALMIC 10 ML, 15 ML; GENTAMICIN DROPS (FORTIFIED) 18MG/ML (1.8%) OPHTHALMIC 5 ML; GENTAMICIN IRRIGATION 1GM/LITER SOLUTION 2000 ML; GENTAMICIN IRRIGATION 480MG/LITER SOLUTION 1000 ML, 2000 ML; GENTAMICIN***(80MGX2ML) 40MG/ML INJECTABLE 100 ML, 100 MLS, 100 VIAL, 12 ML, 14 ML, 150 ML, 200 ML, 25, 40 ML, 50 ML, 50 MLS, 50 VIALS (26 DIFFERENT PRODUCTS) Rx #'s: 0402163 0401103 0361246 0374339 0400819 0401878 0376767 0357627 0358558 0385752 0387435 0388683 0398782 0389025 0389135 0394537 0400051 0410208 0389025 0388231 0391057 0405031 0393211 0393211 0388792 0384288 0407535 0378398 0378398 0377517 0378503 0378504 0380549 0381687 0383319 0385206 0390165 0390166 0390930 0392241 0396501 0396675 0397835 0398312 0398392 0398889 0402538 0402842 0405320 0408916 0378060 0378502 0385165 0399334 0399337 0399340 0399345 0399348 0408326 0405172 0396619 0393974 0378077 0380549 0385218 0399333 0399346 0399349 0399351 0399353 0399354 0399356 0399358 0399361 0399362 0392241 0405640 0402538 0396501 0377276 0377517 0377857 0378077 0379493 0380295 0380549 0380551 0381687 0385218 0387271 0387274 0387280 0387282 0389068 0390166 0390930 0391460 0391463 0391466 0391469 0391576 0391881 0392180 0392182 0392184 0395103 0395519 0396501 0404869 0409343 0409489 0409490 0409492 0410150 0410384 0367933 0395652 0396783 0408328 0402535 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 171 units D-1528-2012
G-C-P 0.1%/0.1%/0.05% SOLUTION 250 ML, 250 MLS, 500 ML (3 DIFFERENT PRODUCTS) Rx #'s: 0400975 0409215 0395770 0359811 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 6 units D-1527-2012
GANCYCLOVIR, SDPF - (30G, 1/2" SYRINGE) 20MG/ML INJECTABLE 1 ML (1 PRODUCT) Rx #: 0397447 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 1 unit D-1526-2012
FORSKOLIN/PHENTOLAMINE 200MCG / 2MG INJECTABLE 5 ML (1 PRODUCT) Rx #: 0395658 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 2 units D-1524-2012
FORSKOLIN/PAPAVARINE/PHENTOLAMINE 200MCG/40MG/3MG/ML INJECTABLE 5 ML; FORSKOLIN/PAPAVARINE/PHENTOLAMINE/ALPROSTADIL 100MCG/30MG/1MG/30MCG/ML INJECTABL 10 ML; (2 DIFFERENT PRODUCTS) Rx #'s: 0402610 0406777 0407425 0407640 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 4 units D-1523-2012
FORMIX 100MCG / 30MG / 1MG INJECTABLE 10 ML, 10 MLS, 5 ML; FORMIX 100MCG / 30MG / 2MG INJECTABLE 10 ML (4 DIFFERENT PRODUCTS) Rx #'s: 0357028 0372461 0374296 0376008 0397681 0407302 0392293 0371718 0396669 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 12 units D-1522-2012
FOLIC ACID 10MG/ML INJECTABLE 60 ML (1 PRODUCT) Rx #: 0398930 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 2 units D-1521-2012
FLUOROURACIL (5-FU) SOLUTION 5% OPHTHALMIC 100 ML; FLUOROURACIL (5-FU) SOLUTION IN ARTIFICIAL TEARS 1% OPHTHALMIC 15 ML; FLUOROURACIL (5-FU) SOLUTION, P.F. 0.001% (10MCG/ML) OPHTHALMIC 20 ML, 30 ML; FLUOROURACIL P.F. 5% INJECTABLE 1000 ML,500 ML, 600 ML; FLUOROURACIL SOLUTION PF 1% OPHTHALMIC 10 ML, 20 ML, 25 ML, 5 ML; FLUOROURACIL, P.F. 1% INJECTABLE 40 ML (12 DIFFERENT PRODUCTS) Rx #'s: 0397776 0377720 0388566 0388566 0379930 0396960 0402574 0379930 0391427 0391427 0391427 0391427 0408750 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 14 units D-1520-2012
FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/10MG VIAL INJECTABLE 12 VIAL, 20 VIAL, 24 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/15MG VIAL INJECTABLE 23 VIAL, 25 VIAL, 30 VIAL, 7 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/5MG VIAL INJECTABLE 1 VIAL, 10 VIAL, 12 VIAL, 13 VIAL, 15 VIAL, 2 VIAL, 20 VIAL, 24 VIAL, 3 VIAL, 30 VIAL, 40 VIAL, 41 VIAL, 5 VIAL, 50 VIAL, 6 VIAL, 7 VIAL, 9 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 300MG/5MG VIAL INJECTABLE 10 VIAL, 15 VIAL, 20 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 300MG/7.5MG VIAL INJECTABLE 20 vials, 6 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 400MG/15MG VIAL INJECTABLE 10 VIAL, 14 VIAL, 15 VIAL, 16 VIAL, 2 VIAL, 20 VIAL, 21 VIAL, 25 VIAL, 250 VIAL, 3 VIAL, 30 VIAL, 32 VIAL, 4 VIAL, 40 VIAL, 5 VIAL, 50 VIAL, 6 VIAL, 8 VIALS, 9 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 500MG/25MG VIAL INJECTABLE 1 VIAL, 12 VIAL, 2 VIAL, 23 VIAL, 30 VIAL, 6 VIAL, 8 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 600MG/12.5MG VIAL INJECTABLE 58 VIAL, 680 VIAL, 692 VIAL, 724 VIAL, 750 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 600MG/15MG VIAL INJECTABLE 2 VIAL, 3 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHYLIZED 1000MG/10MG INJECTABLE 100 VIAL, 137 VIAL, 140 VIAL, 153 VIAL, 200 VIAL, 47 VIAL, 60 VIAL, 63 VIAL (70 DIFFEENT PRODUCTS) Rx #'s: 0387858 0387858 0387858 0360970 0360970 0360970 0360970 0394556 0394868 0388495 0389506 0401222 0406557 0393109 0390858 0406557 0394195 0384679 0390858 0401222 0386372 0393109 0387476 0387651 0394195 0396927 0400464 0384679 0389105 0389105 0389105 0387476 0384679 0388495 0389105 0387476 0392323 0393109 0394195 0390858 0389105 0391704 0391704 0391704 0365030 0392325 0359065 0364511 0365182 0366253 0366265 0370058 0384847 0387893 0387894 0388887 0392782 0393234 0393654 0395364 0400787 0401230 0408490 0394164 0350907 0354075 0364511 0370058 0384847 0387894 0388887 0392782 0393234 0394910 0395364 0410310 0394449 0388820 0354075 0364600 0370665 0393234 0393654 0394164 0395364 0400787 0370665 0349864 0384847 0403576 0370058 0366253 0388820 0370058 0370058 0373554 0370665 0393234 0359065 0366368 0373554 0384847 0387893 0387894 0388887 0393915 0394164 0390169 0394074 0394164 0400289 0389633 0394449 0394557 0388093 0382934 0379184 0379184 0388093 0394557 0388093 0390228 0390228 0390228 0390228 0390228 0403847 0403851 0387650 0396924 0358285 0376244 0397588 0404422 0404430 0376244 0376244 0376244 0376244 0376244 0376244 0376244 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 202 units D-1519-2012
INDOCYANINE GREEN - KIT 15MG INJECTABLE 1 KIT, 100 KIT, 12 KIT, 20 KIT, 50 KIT, 6 KIT, 75 KIT, 8 KIT; INDOCYANINE GREEN - KIT 1MG INJECTABLE 1 KIT, 10 `KIT, 10 KIT, 100 KIT, 18 VIAL, 2 KIT (51 DIFFERENT PRODUCTS) 2 VIAL 20 KIT 22 KITS 25 KITS 3 KITS 3 VIALS 4 VIALS 5 KIT 50 KIT 50 KITS 6 KIT 60 KIT 8 KIT INDOCYANINE GREEN - KIT 25MG INJECTABLE 1 KIT 6 KIT INDOCYANINE GREEN - KIT 30MG INJECTABLE 10 KIT 14 KIT 25 KIT 5 KIT INDOCYANINE GREEN - KIT 5MG INJECTABLE 1 KIT 10 KIT 12 KIT 15 KIT 15 VIAL 2 KIT 20 KIT 25 KIT 3 KIT 4 KIT 5 KIT 6 KIT 8 KIT INDOCYANINE GREEN, LYOPHILIZED 15MG VIAL 1 VIAL INDOCYANINE GREEN, LYOPHILIZED 1MG VIAL 2 VIAL 5 VIAL INDOCYANINE GREEN, LYOPHILIZED 5MG VIAL 1 VIAL 2 KIT Rx #'s: 0392321 0394025 0388514 0401919 0350642 0394025 0388514 0394025 0388514 0390732 0390733 0390734 0390735 0390736 0390737 0390738 0380350 0368327 0374556 0367241 0389528 0387672 0387673 0388017 0388019 0388022 0388506 0388512 0388515 0392608 0392615 0392616 0392619 0392621 0396198 0396215 0396216 0396229 0396231 0399438 0399439 0399442 0399445 0403009 0403010 0403011 0403012 0403013 0406259 0406260 0406262 0406344 0407979 0407983 0407994 0407995 0407997 0389528 0380350 0391097 0391097 0391097 0394711 0394711 0396280 0396282 0401229 0401451 0403261 0403264 0403265 0403266 0406344 0367241 0391097 0360638 0360913 0370332 0374556 0367241 0368572 0374556 0390415 0396119 0381037 0381037 0409349 0381037 0407487 0369244 0398000 0400203 0369244 0401228 0365406 0381433 0382639 0397201 0408640 0398000 0366257 0366257 0381433 0387899 0408486 0381433 0387899 0397201 0401228 0382639 0403456 0358087 0394872 0401833 0403472 0392320 0360357 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 134 units D-1546-2012
HYPERTONIC SOLUTION IN PRESERVED WATER 10% INJECTABLE 50 ML (1 PRODUCT) Rx #: 0388007 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 3 units D-1545-2012
HYDROXYPROGESTERONE CAPROATE 250MG/ML INJECTABLE 10 ML, 12 ML, 13 ML, 15 ML, 3 ML, 30 ML, 4 ML, 5 ML, 6 ML, 7 ML, 9 ML (11 DIFFERENT PRODUCTS) Rx #'s: 0389566 0391189 0400011 0363726 0384953 0389818 0389944 0391513 0394424 0398045 0399810 0400508 0400659 0400899 0402416 0406767 0408616 0408784 0409002 0394645 0404250 0404253 0383078 0390794 0396149 0407773 0380431 0400011 0408013 0385258 0396543 0400011 0386991 0398045 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 48 units D-1544-2012
ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, 3 ML, 30 ML, 5 ML, 6 ML; ALPROSTADIL 15MCG/ML INJECTABLE 5 ML; ALPROSTADIL 20MCG/ML INJECTABLE 10 ML, 10 MLS, 20 ML, 3 ML, 30 ML, 4 ML, 40 ML, 5 ML, 6 ML; ALPROSTADIL 24MCG/ML INJECTABLE 6 ML; ALPROSTADIL 25MCG/ML INJECTABLE 10 ML; ALPROSTADIL 30MCG/ML INJECTABLE 10 ML; ALPROSTADIL 35MCG/ML INJECTABLE 10 ML; ALPROSTADIL 40MCG/ML INJECTABLE 10 ML, 10 ML, 10 VIAL, 15 ML, 2 ML, 20 ML, 3 ML, 30 ML, 40 ML, 5 ML, 50 ML, 6 ML; ALPROSTADIL 50MCG/ML INJECTABLE 10 ML, 2 ML, 20 ML, 5 ML; ALPROSTADIL 60MCG/ML INJECTABLE 20 ML; ALPROSTADIL (M) 500MCG/ML INJECTABLE 10 ML; ALPROSTADIL 100MCG/ML INJECTABLE 5 ML; ALPROSTADIL, STERILE 1,000MCG/ML GEL 10 ML, 12 ML, 20 ML, 3 ML, 30 ML, 6 ML; ALPROSTADIL/PAPAVERINE 10MCG/9MG/ML INJECTABLE; ALPROSTADIL/PHENT 10MCG/0.5MG/ML INJECTABLE 10 ML, 5 ML; ALPROSTADIL/PHENT 17MCG/0.5MG/ML INJECTABLE 10 ML; ALPROSTADIL/PHENTOLAMINE 40MCG/2MG/ML INJECTABLE 10 ML (50 DIFFERENT PRODUCTS) Rx #'s: 0358246, 0364805, 0368284, 0378756, 0380820, 0387648, 0388175, 0388294, 0388761, 0391370, 0393218, 0393296, 0394349, 0394946, 0395082, 0395861, 0396187, 0398267, 0401319, 0404291, 0405612, 0388186, 0399034, 0386335, 0400431, 0407531, 0358246, 0378756, 0388743, 0400047, 0404363, 0388082, 0409372, 0348455, 0350663, 0353518, 0355129, 0355693, 0356375, 0357470, 0357616, 0358082, 0358244, 0358434, 0359158, 0363285, 0365259, 0367960, 0369601, 0370844, 0370856, 0371600, 0372364, 0373144, 0373375, 0373510, 0374111, 0374998, 0375459, 0375602, 0376024, 0376332, 0376872, 0377260, 0377875, 0377985, 0379138, 0379565, 0381219, 0383350, 0383828, 0383945, 0385030, 0386074, 0386125, 0386686, 0386742, 0387013, 0387677, 0387846, 0387958, 0388044, 0388436, 0388779, 0388809, 0389393, 0389418, 0389598, 0390069, 0390100, 0390105, 0390505, 0390514, 0390727, 0390999, 0391218, 0391382, 0391595, 0391844, 0391948, 0391988, 0392128, 0392227, 0392536, 0392693, 0392724, 0393539, 0393726, 0393837, 0393890, 0394052, 0394339, 0394442, 0394610, 0394740, 0394779, 0394933, 0395044, 0395610, 0396031, 0396423, 0396428, 0396488, 0396514, 0396850, 0396858, 0396885, 0397148, 0397215, 0397247, 0397393, 0397721, 0397747, 0398357, 0398790, 0398832, 0399045, 0399061, 0399186, 0399368, 0399512, 0399565, 0399867, 0400110, 0400648, 0400692, 0401141, 0401171, 0401436, 0401685, 0401963, 0402524, 0402833, 0402836, 0403131, 0403599, 0403651, 0403776, 0404125, 0404206,0404594,0405337, 0405746, 0406186, 0406350, 0406503, 0406533, 0406608, 0406961, 0407011, 0407522, 0407608, 0408149, 0408243, 0408471, 0408475, 0408733, 0408803, 0408948, 0409227, 0409652, 0408211, 0370597, 0372090, 0372291, 0377260, 0383350, 0384600, 0386742, 0387759, 0394740, 0395554, 0398507, 0399696, 0400665, 0407851, 0384600, 0390561, 0390730, 0391280, 0404039, 0398586, 0387759, 0363140, 0373946, 0379198, 0381414, 0388131, 0390621, 0391087, 0396493, 0402322, 0406179, 0406683, 0407311, 0407850, 0408048, 0392605, 0378371, 0388907, 0391868, 0390192, 0396500, 0352172, 0357035, 0358183, 0358360, 0360788, 0366242, 0366923, 0368523, 0369902, 0374538, 0375333, 0375959, 0377935, 0378040, 0378351, 0379207, 0381237, 0382171, 0385235, 0386937, 0387960, 0388158, 0388210, 0388404, 0388444, 0388445, 0388596, 0388605, 0389108, 0389341, 0389709, 0390347, 0390351, 0390846, 0391197, 0391199, 0391635, 0391700, 0391753, 0392003, 0392022, 0392047, 0392213, 0392423, 0392641, 0392690, 0393922, 0394131, 0394193, 0394388, 0394635, 0394718, 0394798, 0395372, 0395626, 0395876, 0396249, 0396718, 0397811, 0398107, 0398194, 0398343, 0398844, 0398887, 0398982, 0399110, 0399320, 0399528, 0399765, 0400046, 0400096, 0400297, 0400421, 0400424, 0400598, 0400913, 0401400, 0401500, 0401680, 0401934, 0402088, 0402325, 0402328, 0402586, 0402967, 0403274, 0403345, 0403607, 0404401, 0405474,0405498, 0405724, 0406291, 0406457, 0406542, 0407511, 0408231, 0409030, 0409062, 0409526, 0409607, 0409759, 0410307, 0393753, 0397762, 0403540, 0374221, 0382214, 0395621, 0397852, 0402288, 0406445, 0399687, 0374221, 0366701, 0351976, 0354103, 0384453, 0390423, 0391629, 0393615, 0396582, 0397827, 0398720, 0399013, 0403466, 0406583, 0409862, 0397208, 0361392, 0379145, 0380920, 0387005, 0400616, 0404590, 0404931, 0396725, 0392873, 0357803, 0363807, 0365784, 0370228, 0372609, 0376996, 0377620, 0378319, 0380457, 0381999, 0382394, 0382527, 0382743, 0382990, 0386135, 0386929, 0387451, 0387674, 0389081, 0389143, 0389875, 0390000, 0390409, 0391030, 0391711, 0392245, 0392563, 0392705, 0392767, 0393396, 0393794, 0394466, 0395061, 0396510, 0397503, 0397715, 0397737, 0397916, 0397953, 0398923, 0399635, 0399757, 0399812, 0400282, 0400880, 0402467, 0403426, 0403519, 0403728, 0403832, 0404015, 0404522, 0405565, 0405585, 0406128, 0406628, 0407265, 0407357, 0407736, 0407839, 0408178, 0408378, 0409610, 0409944, 0388717, 0394665, 0367237, 0368886, 0401105, 0395886, 0397863, 0388295, 0387427, 0388295, 0397030 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 529 units D-1452-2012
AFLIBERCEPT, SDPF - (0.05ML SYRINGE, 31G, 5/16") 40MG/ML INJECTABLE 0.35 ML, 0.95 ML, 1.25 ML (3 DIFFERENT PRODUCTS) Rx #'s: 0391287, 0398843, 0398843 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 4 units D-1451-2012
ACYCLOVIR OPHTHALMIC 3% OINTMENT 5 GM; ACYCLOVIR OPHTHALMIC 3% SOLUTION 5 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0384117, 0407161 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 3 units D-1450-2012
ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 10% SOLUTION 10 ML, 2 ML, 5 ML, 6 ML; ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 2.5% SOLUTION 20 ML; ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 5% SOLUTION 3 ML (6 DIFFERENT PRODUCTS) Rx #'s: 0398691, 0401304, 0403533, 0385192, 0407592, 0394079, 0388572, 0391271, 0400529 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 16 units D-1449-2012
ACETIC ACID, IRRIGATION 3% SOLUTION 500 ML (1 PRODUCT) Rx #: T0389114 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 2 units D-1448-2012
ACETAZOLAMIDE, LYOPHILIZED 500MG INJECTABLE10 VIAL, 4 VIAL, 5 VIAL, 6 VIAL, 8 VIAL (5 DIFFERENT PRODUCTS) Rx #'s: 0390522, 0390522, 0353081, 0390522, 0390522, 0398989 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 10 units D-1447-2012
FENTANYL, P.F. 100MCG/ML INJECTABLE 12 ML, 2 ML, 30 ML, 60 ML; FENTANYL, P.F. 50MCG/ML (100MCG/2ML) INJECTABLE 100 ML, 120 ML, 150 ML, 20 ML, 200 ML, 24 ML, 250 ML, 30 ML, 300 ML, 40 ML, 400 ML, 50 ML, 60 ML; FENTANYL, WITH PRESERVATIVES 50MCG/ML INJECTABLE 30 ML (18 DIFFERENT PRODUCTS) Rx #'s:N0395099 N0389078 N0389083 N0389084 N0389085 N0389086 N0389089 N0389090 N0389093 N0389095 N0389097 N0389099 N0389100 N0390325 N0390326 N0390328 N0390329 N0390331 N0390332 N0390333 N0390338 N0390377 N0390380 N0390382 N0390383 N0390385 N0390390 N0390393 N0392339 N0392343 N0392344 N0392345 N0392347 N0392349 N0392351 N0392353 N0392354 N0392355 N0392357 N0392360 N0392363 N0392364 N0392367 N0392368 N0392370 N0392372 N0392374 N0392375 N0397646 N0397796 N0397797 N0397798 N0397802 N0397803 N0397804 N0397805 N0397806 N0397807 N0397990 N0397993 N0397994 N0397996 N0397997 N0398016 N0398017 N0398019 N0398020 N0398021 N0396955 N0398306 N0405187 N0401002 N0396784 N0398527 N0400271 N0400917 N0407735 N0409318 N0398310 N0408255 N0399153 N0404847 N0398297 N0399447 N0403452 N0406065 N0409741 N0397353 N0398612 N0406345 N0408105 N0393498 N0395106 N0401234 N0402072 N0402652 N0406677 N0397637 N0400888 N0398823 N0399918 N0400676 N0404455 N0398592 N0409187 N0393520 N0394243 N0406426 N0407548 N0397583 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 110 units D-1518-2012
ETOMIDATE 0.2% (2MG/ML) INJECTABLE 20 ML (1 PRODUCT) Rx #: 0403172 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 1 unit D-1517-2012
ETHYL ALCOHOL 10% INJECTABLE 30 ML; ETHYL ALCOHOL 100%INJECTABLE 10 ML, 100 ML, 20 ML, 40 ML, 5 ML, 60 ML; ETHYL ALCOHOL 20% INJECTABLE 5 ML; ETHYL ALCOHOL 5% INJECTABLE 180 ML, 30 ML; ETHYL ALCOHOL 95% INJECTABLE 10 ML, 8 ML; ETHYL ALCOHOL OPHTHALMIC 40% INJECTABLE 50 ML (13 DIFFERENT PRODUCTS) Rx #'s: 0378831 0387603 0391286 0391286 0391286 0396237 0391286 0401965 0392266 0406349 0360543 0406198 0360543 0398555 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 17 units D-1516-2012
ESTRADIOL 25MG PELLETS 1 PELLET, 15 PEL, 15 PELLET, 2 PELLET, 2 TAB, 3 PELLET, 4 PELLET, 6 PELL, 6 PELLET; ESTRADIOL 50MG PELLETS 1 PELELT, 1 PELLET, 4 PELLET, 6 PELLET; ESTRADIOL CYPIONATE 5MG/ML INJECTABLE 5 ML; ESTRADIOL VALERATE IN COTTONSEED OIL 40 MG/ML INJECTABLE 10 ML; ESTRADIOL VALERATE IN SESAME OIL 40 MG/ML INJECTABLE 10 ML (16 DIFFERENT PRODUCTS) Rx #'s: 0389464 0398833 0399748 0402917 0402926 0405892 0404079 0404086 0392875 0398067 0403137 0403795 0404506 0408694 0404895 0387492 0389813 0390461 0391264 0391818 0391961 0392952 0393766 0395543 0396232 0396925 0397181 0397313 0397959 0399219 0400227 0400749 0400845 0401497 0401998 0402465 0402997 0403162 0405298 0405330 0405341 0406903 0407419 0408021 0409309 0409791 0402406 0402414 0389982 0389976 0407175 0386101 0391782 0394584 0399576 0403154 0403358 0404795 0406532 0409701 0410127 0400234 0389894 0369509 0407537 0387936 0388504 0401671 0391774 0395019 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 72 units D-1515-2012
EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJECTABLE 25 ML; EPINEPHRINE HCL SOLUTION 1% OPHTHALMIC 10 ML, 20 ML; EPIINEPHRINE P.F. (SULFITE-FREE) 1:1,000 (1MG/ML) INJECTABLE 1 ML, 2 ML, 20 ML, 25 ML, 3 ML, 30 ML, 4 ML, 5 ML, 50 ML; EPINEPHRINE PF IN BSS, OPHTHALMIC (CONTAINS SULFITES) 1:1000 (1MG/ML) INJECTABLE 15 ML, 16 ML, 30 ML (15 DIFFERENT PRODUCTS) Rx #'s: 0397555 0397557 0382534 0400837 0407829 0390562 0390562 0395167 0397757 0396775 0394599 0390562 0396775 0390562 0390562 0396775 0389984 0387701 0389984 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 33 units D-1514-2012
DEXPANTHENOL 250MG/ML INJECTABLE 100 ML, 120 ML, 360 ML, 450 ML (4 DIFFERENT PRODUCTS) Rx #: 0370657 0391175 0397241 0397241 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 5 units D-1499-2012
DEXAMETHASONE/BACTERIOSTATIC WATER IONTOPHORESIS 0.5MG/5ML(0.1MG/ML) INJECTABL 30 ML (1 PRODUCT) 40 ML DEXAMETHASONE SDPF (0.1ML SYRINGE, 31G, 5/16" ) 0.4MG/ML INJECTABLE 0.3 ML 0.5 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 10MG/ML (1%) INJECTABLE 0.05 ML 1 ML 16 ML 2 ML 24 ML 3 ML 32 ML 8 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 4MG/ML (0.4%) INJECTABLE 0.4 ML 2 ML 3 ML 5 ML 6 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 80MG/ML (8%) INJECTABLE 100 ML 40 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 8MG/ML (800MCG/0.1ML) INJECTABLE 0.1 ML DEXAMETHASONE SODIUM PHOSPHATE 40MG/ML INJECTABLE 50 ML DEXAMETHASONE SODIUM PHOSPHATE 4MG/ML INJECTABLE 100 ML 180 MLS 240 MLS 30 ML 60 ML DEXAMETHASONE SODIUM PHOSPHATE IN BSS (P.F.) 10MG/ML (1%) INJECTABLE 1 ML DEXAMETHASONE SODIUM PHOSPHATE, 30ML VIAL** 4MG/ML INJECTABLE 30 ML DEXAMETHASONE SOLUTION - NACL, P.F. 0.1% OPHTHALMIC 15 ML DEXAMETHASONE, SDPF - (0.07ML SYRINGE, 30G, 1/2") 80MG/ML INJECTABLE 0.35 ML 0.7 ML Rx #: 0400257 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 1 unit D-1498-2012
DEXAMETHASONE SODIUM PHOSPHATE PF 0.04% OPHTHALMIC 2 ML; DEXAMETHASONE / LIDOCAINE 0.5%/3% INJECTABLE 30 MLS; DEXAMETHASONE ACETATE (LA) 8MG/ML INJECTABLE 100 ML; DEXAMETHASONE IONTOPHORESIS, STERILE, P.F. 4MG/ML SOLUTION 20 ML, 30 ML (35 DIFFERENT PRODUCTS) 40 ML DEXAMETHASONE SDPF (0.1ML SYRINGE, 31G, 5/16" ) 0.4MG/ML INJECTABLE 0.3 ML 0.5 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 10MG/ML (1%) INJECTABLE 0.05 ML 1 ML 16 ML 2 ML 24 ML 3 ML 32 ML 8 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 4MG/ML (0.4%) INJECTABLE 0.4 ML 2 ML 3 ML 5 ML 6 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 80MG/ML (8%) INJECTABLE 100 ML 40 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 8MG/ML (800MCG/0.1ML) INJECTABLE 0.1 ML DEXAMETHASONE SODIUM PHOSPHATE 40MG/ML INJECTABLE 50 ML DEXAMETHASONE SODIUM PHOSPHATE 4MG/ML INJECTABLE 100 ML 180 MLS 240 MLS 30 ML 60 ML DEXAMETHASONE SODIUM PHOSPHATE IN BSS (P.F.) 10MG/ML (1%) INJECTABLE 1 ML DEXAMETHASONE SODIUM PHOSPHATE, 30ML VIAL** 4MG/ML INJECTABLE 30 ML DEXAMETHASONE SOLUTION - NACL, P.F. 0.1% OPHTHALMIC 15 ML DEXAMETHASONE, SDPF - (0.07ML SYRINGE, 30G, 1/2") 80MG/ML INJECTABLE 0.35 ML 0.7 ML Rx #'s: 0406046 0397385 0366980 0395509 0387345 0387381 0387586 0387752 0391041 0391584 0394112 0394246 0395288 0397054 0397946 0399555 0400910 0401208 0403442 0404123 0408115 0388847 0388144 0388144 0395892 0389202 0373332 0378850 0388550 0392222 0373332 0378850 0388550 0373332 0373332 0378850 0358046 0376175 0392337 0375442 0392337 0377047 0381838 0388945 0407636 0371528 0375458 0375458 0400150 0368414 0366367 0389059 0392819 0407227 0368231 0390906 0405998 0364593 0409797 0364593 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 73 units D-1497-2012
DAPIPRAZOLE OPHTHALMIC 0.5% SOLUTION 10 ML; DAPIPRAZOLE, LYOPHILIZED, OPHTHALMIC KIT 0.5% POWDER 1 KIT, 10 KIT, 2 KIT, 3 KIT, 4 KIT, 6 KIT (7 DIFFERENT PRODUCTS) Rx #'s: 0402838 0366311 0393844 0405862 0369802 0361586 0362348 0367636 0354323 0361586 0376846 0395405 0401667 0404458 0356814 0372189 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 25 units D-1495-2012
COPPER GLUCONATE 2MG/ML INJECTABLE 30 ML, 60 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0398939 0389889 0398939 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 3 units D-1487-2012
CLINDAMYCIN OPHTHALMIC (PF) 20MG/ML (2MG/0.1ML) SOLUTION 2 ML; CLINDAMYCIN PHOSPHATE OPHTHALMIC, INTRAVITREAL (P.F.) 1MG/0.1ML INJECTABLE 0.2 ML; CLINDAMYCIN PHOSPHATE SDPF- (0.1ML SYRINGE,30G,1/2") 1MG/0.1ML INJECTABLE 0.1 ML (3 DIFFERENT PRODUCTS) Rx #'s: 0397741 0402847 0396295 0394438 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 5 units D-1486-2012
CISPLATIN 1MG/ML INJECTABLE 1000 ML, 2000 ML (2 DIFFERENT PRODUCTS) Rx #"s: 0392538 0391562 0391564 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 3 units D-1485-2012
CHROMIUM PICOLINATE 200MCG/ML INJECTABLE 60 ML (1 PRODUCT) Rx #'s: 0353549 0398279 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 4 units D-1484-2012
CHORIONIC GONADOTROPIN (STANDARD) - 21 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD) - 45 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD)-21 DAY 125 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD)-45 DAY 125 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN + B12, LYOPHILIZED 4,000 UNIT/40MCG/ML KIT 1 KIT, 2 KIT, 3 KIT; CHORIONIC GONADOTROPIN + B12, LYOPHILIZED (HCG) 4,000 UNIT VIAL INJECTABLE 1 VIAL, 12 VIALS; CHORIONIC GONADOTROPIN KIT 5,000 UNIT VIAL INJECTABLE 1 KIT; CHORIONIC GONADOTROPIN** KIT 10,000 UNIT VIAL INJECTABLE 1 KIT; CHORIONIC GONADOTROPIN, HUMAN - MINI 250 UNITS TROCHE 30 TROCHE, 45 TROCHE, 50 TROCHE, 60 TROCHE, 80 TROCHE; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 1,000 UNIT VIAL INJECTABLE 30 VIAL; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 5,000 UNIT VIAL INJECTABLE 1 VIAL, 10 VIAL, 14 VIAL, 15 VIAL, 2 VIAL, 2 VIALS, 20 VIAL, 3 VIAL, 5 VIAL, 6 VIAL; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 125 UNIT VIAL (UNIT DOSE) INJECTABLE 10 VIAL, 14 VIAL, 15 VIAL, 2 VIAL, 24 VIAL, 28 VIAL, 28 VIALS, 7 VIAL, 7 VIALS; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 2,500 UNIT VIAL INJECTABLE 5 VIAL; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 200 UNIT VIAL (UNIT DOSE) INJECTABLE 22 VIAL, 25 VIAL, 8 VIAL (40 DIFFERENT PRODUCTS) Rx #'s: 0389332 0388230 0362007 0362537 0369266 0369759 0376765 0376766 0378972 0381347 0381668 0383006 0384070 0387408 0387842 0387873 0388522 0388825 0389034 0389038 0389347 0389746 0389824 0389913 0390210 0390265 0390267 0390404 0390481 0391083 0391374 0391789 0392302 0392329 0393161 0393238 0393733 0393734 0394038 0396204 0396253 0396951 0397068 0397814 0397816 0398167 0398775 0398809 0399039 0399168 0400419 0401454 0401456 0401717 0402440 0402443 0403637 0377693 0382907 0389892 0390269 0393418 0397085 0397984 0398761 0401192 0401453 0401702 0402969 0403042 0353856 0380968 0389852 0396383 0396985 0397369 0405720 0409461 0400111 0392017 0405577 0405591 0407190 0390553 0410265 0393727 0394656 0399169 0403590 0392209 0392212 0392214 0392215 0392217 0394902 0395795 0395799 0395800 0395880 0395884 0395885 0398821 0399797 0403933 0405574 0405578 0405607 0405608 0406394 0410495 0394528 0395347 0392045 0393681 0393682 0394381 0396742 0396763 0401783 0401785 0405205 0404805 0397298 0398209 0401610 0404696 0406424 0408386 0408794 0409008 0409330 0409500 0409511 0410093 0410179 0410202 0410327 0394569 0397231 0400352 0400360 0410043 0410045 0410046 0394569 0394569 0407106 0407854 0409176 0408788 0394569 0405634 0394765 0405634 0392318 0394569 0373437 0381856 0387413 0397985 0398350 0394512 0401471 0404558 0393614 0397800 0387413 0406999 0397800 0397822 0388830 0380110 0407385 0380110 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 193 units D-1483-2012
EDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML; EDTA CALCIUM DISODIUM (PRESERVATIVE FREE) 150MG/ML INJECTABLE 100 ML, 2400 ML, 500 ML; EDTA CALCIUM DISODIUM SOLUTION 2% OPHTHALMIC 5 ML; EDTA DISODIUM (P.F.) 150MG/ML INJECTABLE 1000 ML, 1200 ML, 1500 ML, 400 ML, 500 ML, 900 ML; EDTA DISODIUM (PRESERVATIVE FREE) 150MG/ML INJECTABLE 1000 ML, 2000 ML, 8000 ML; EDTA DISODIUM (PRESERVATIVE FREE) 3%/ML INJECTABLE 12 ML; EDTA DISODIUM IN NATURAL TEARS 1.5% OPHTHALMIC 5 ML; EDTA DISODIUM IN NATURAL TEARS 3% OPHTHALMIC 15 ML, 30 ML (18 DIFFERENT PRODUCTS) Rx #'s: 0388316 0388963 0389126 0389635 0391611 0406215 0395252 0392864 0395978 0390748 0390748 0390748 0391630 0391630 0390748 0400319 0388489 0388489 0389320 0390209 0403997 0382211 0381428 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 28 units D-1512-2012
EDETATE DISODIUM PF IN BSS 3% OPHTHALMIC 10 ML; EDETATE DISODIUM SOLUTION IN ARTIFICIAL TEARS 0.05% OPHTHALMIC 10 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0397185 0408097 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 2 units D-1511-2012
DROPTAINER STERILE PLASTIC (2 X 7ML) 10 BOTTLE 4 PK (2 DIFFERENT PRODUCTS) Rx #'s: T0395419 T0393096 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 2 units D-1510-2012
DOXORUBICIN HCL, LYOPHILIZED 10MG VIAL 2 VIAL; DOXORUBICIN HCL, LYOPHILIZED 50MG VIAL 1 VIAL, 10 VIAL, 5 VIAL (4 DIFFERENT PRODUCTS) Rx #'s: 0393869 0393871 0356246 0357036 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 4 units D-1509-2012
DMSO/VITAMIN C/GLUTATHIONE SOLUTION 6.25%/1.25%/1.25% OPHTHALMIC 10 ML, 15 ML, 5 ML (3 DIFFERENT PRODUCTS) Rx #'s: 0393533 0387959 0366146 0395006 0401280 0408662 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 9 units D-1508-2012
DMSO/HEPARIN/METHYLPREDNISOLONE 50%/5000U/40MG/50ML SOLUTION 300 MLS (1 PRODUCT) Rx #: 0384672 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 2 units D-1507-2012
DMSO/HEPARIN 50%/20,000U/25ML SOLUTION 100 ML, 25 ML; DMSO/HEPARIN 50%/5000U/50ML SOLUTION 300 ML, 400 ML (4 DIFFERENT PRODUCTS) Rx #'s: 0405376 0386923 0397004 0397004 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 8 units D-1506-2012
CYCLOSPORINE (A) AQUEOUS (HUMAN) 0.5% OPHTHALMIC 10 ML, 5 ML; CYCLOSPORINE (A) AQUEOUS PF (HUMAN) 0.2% OPHTHALMIC 10 ML; CYCLOSPORINE (A) AQUEOUS PF (HUMAN) 1% OPHTHALMIC 10 ML; CYCLOSPORINE (A) CORN OIL SOLUTION 2% OPHTHALMIC 15 ML; CYCLOSPORINE (A) OIL SOLUTION 1% OPHTHALMIC 10 ML, 20 ML, 60 ML; CYCLOSPORINE (A) OIL SOLUTION 2% OPHTHALMIC 10 ML, 15 ML, 20 ML, 30 ML (12 DIFFERENT PRODUCTS) Rx #'s: 0398633 0374138 0407059 0395611 0366358 0382466 0385492 0405984 0407947 0409833 0369221 0401142 0364989 0385219 0389327 0389381 0395535 0402826 0406693 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 40 units D-1494-2012
CYCLOPENTALATE/PHENYLEPHRINE 1%/2.5% OPHTHALMIC 5 ML (1 PRODUCT) Rx #: 0387441 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 1 unit D-1493-2012
CYCLOPENT/PHENYLEPH/TROPICAMIDE/PROPARACAINE 2%/2.5%/1%/0.5% OPHTHALMIC 5 ML (1 PRODUCT) Rx #: 0387447 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 1 unit D-1492-2012
CYCLOPENT/LIDOCAINE/PHENYLEPHRINE/TROPICAMIDE 0.5%/0.5%/0.625%/0.25% OPHTHALMIC 20 ML (1 PRODUCT) Rx #: 0392313 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 1 unit D-1491-2012
CYCLOPENT/KETOROLAC/PHENYLEPH/TROPICAMIDE 1%/0.5%/2.5%/1% OPHTHALMIC 70 ML (1 PRODUCT) Rx #'s: 0358393 0400281 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 3 units D-1490-2012
CYCLOPENT/FLURBIPR/PHENYLEPH/PROPARACAINE .25%/0.0075%/0.625%/0.125% OPHTHALMIC 56 ML, 70 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0368702 0368702 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 6 units D-1489-2012
CYANOCOBALAMIN (VIT B12 ) 1,000MCG/ML INJECTABLE 1 ML, 10 ML, 100 ML, 12 ML, 120 ML, 15 ML, 150 ML, 180 ML, 2 ML, 200 ML, 3 ML, 30 ML, 300 ML, 32 ML, 4 ML, 5 ML, 6 ML, 60 ML, 90 ML; CYANOCOBALAMIN **1000MCG/ML INJECTABLE 1000MCG/ML INJECTABLE 30 ML; CYANOCOBALAMIN*** (25X10ML VIAL) 1000MCG/ML INJECTABLE 10 ML, 20 MLS, 40 ML; CYANOCOBALMIN ***(VIT B-12) 25X1ML 1000MCG/ML INJECTABLE 50 MLS (24 DIFFERENT PRODUCTS) Rx #'s: 0387434 0387442 0373259 0379220 0379925 0381812 0382155 0389481 0391043 0391912 0392598 0393303 0397302 0368903 0385563 0377621 0389560 0376591 0387169 0375580 0388039 0381499 0387434 0387442 0368903 0398369 0385601 0381154 0382450 0395591 0399380 0400168 0401501 0375406 0388039 0370251 0379203 0380414 0373568 0373668 0379036 0376722 0380943 0381499 0384292 0388741 0395917 0373742 0387702 0389521 0373742 0401945 0409583 0404840 0407920 0407921 0407922 0407923 0407925 0407926 0407928 0407931 0407933 0407935 0403019 0406664 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 86 units D-1488-2012
CEFTAZIDIME OPHTHALMIC, P.F. 22.5MG/ML (2.25%) OPHTHALMIC 1 ML, 2ML, 2 MLS, 6 ML CEFTAZIDIME, LYOPHILIZED, OPHTHALMIC KIT 2.25% KIT 1 KIT 12 KIT 16 KIT 2 KIT 2 KITS 20 KIT 3 KIT 3 KITS 4 KIT 4 KITS 4 VIALS 5 KIT 6 KIT 6 VIAL 8 KIT CEFTAZIDIME, SDPF - (0.2ML SYRINGE, 30G, 1/2") 2.25% INJECTABLE 0.2 ML 0.4 ML 0.6 ML 0.8 ML 1.2 ML 1.6 ML (25 DIFFERENT PRODUCTS) Rx #'s: 0400830 0400830 0403915 0369559 0382655 0355231 0363469 0364194 0364586 0365232 0368229 0368502 0368575 0379338 0379547 0383465 0387854 0389349 0390953 0391076 0392073 0394447 0394682 0394934 0395429 0395951 0396729 0397109 0397667 0404203 0404799 0405703 0406025 0408991 0359179 0359179 0348862 0356877 0360153 0363384 0363885 0364194 0364239 0366032 0366271 0368245 0368882 0376169 0380550 0382237 0384296 0385288 0387375 0387380 0387486 0388896 0389392 0390771 0392073 0394447 0399970 0399989 0403141 0403755 0405329 0365743 0384729 0389303 0396299 0353130 0355933 0356625 0362693 0363384 0363667 0368575 0368882 0371797 0375692 0380344 0383379 0387330 0387486 0388896 0392336 0392543 0395951 0396870 0402552 0409017 0375411 0395390 0358612 0362693 0366271 0371046 0375511 0375514 0375515 0375518 0375519 0375692 0384296 0387483 0392020 0392336 0408625 0376091 0399724 0356877 0405109 0408823 0362693 0371046 0375356 0375503 0375504 0375506 0375507 0375510 0375511 0375514 0375515 0375518 0375519 0392020 0392336 0396870 0398875 0368836 0354413 0398562 0354048 0389058 0389206 0405941 0358048 0387432 0402040 0391715 0391715 0393524 0404316 0391708 0402008 0391708 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 197 units D-1482-2012
CEFAZOLIN IN ARTIFICIAL TEARS 50MG/ML OPHTHALMIC 10 ML; CEFAZOLIN VIAL*(25X1GM) 1GM INJECTABLE 10 VIAL (2 DIFFERENT PRODUCTS) Rx #'s: 0408353 0404128 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 2 units D-1481-2012
CALCIUM CHLORIDE DIHYDRATE, P.F. 100MG/ML (10%) INJECTABLE 200 ML, 240 ML, 500 ML; CALCIUM EDTA 150MG/ML INJECTABLE 1000 ML, 800 ML, 900 ML; CALCIUM EDTA 300MG/ML INJECTABLE 400 ML, 500 ML; CALCIUM GLUCONATE OPHTHALMIC IN ARTIFICIAL TEARS 1% OPHTHALMIC 500 ML (9 DIFFERENT PRODUCTS) Rx #'s: 0392865 0396841 0392865 0389079 0401264 0401264 0389079 0351538 0379811 0398960 0396622 0367514 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 21 units D-1480-2012
BUPIVACAINE/SUFENTANIL, P.F. 15MG/150MCG/ML INTRATHECAL 20 ML (1 PRODUCT) Rx #:N0390025 N0399831 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 2 units D-1479-2012
BUPIVACAINE/MORPHINE SULFATE, P.F. 2.5MG/10MG/ML INTRATHECAL 40 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/25MG/ML INTRATHECAL 20 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/50MG/ML INTRATHECAL 18 ML, 35 ML (4 DIFFERENT PRODUCTS) Rx #'s:N0396140 N0408047 N0390990 N0400772 N0387610 N0391586 N0393141 N0396643 N0398235 N0402376 N0404186 N0409166 N0410206 N0387612 N0394426 N0402375 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 16 units D-1478-2012
DMSO / BUPIVACAINE HCL 50%/0.5% INJECTABLE 100 ML, 50 ML; DMSO 100% INJECTABLE 100 ML; DMSO FORTIFIED IRRIGATION - W/O HEPARIN SOLUTION 350 ML; DMSO FORTIFIED IRRIGATION 50%/0.01%/44%/1% SOLUTION 1000 ML, 1200 ML, 150 ML, 200 ML, 250 ML, 300 ML, 400 ML, 500 ML, 600 ML; DMSO FORTIFIED IRRIGATION 50%/44%/1% SOLUTION 50 ML; DMSO FORTIFIED IRRIGATION W/LIDOCAINE 50%/0.01%/44%/1%/1% SOLUTION 250 ML; DMSO IRRIGATION - NACHO3 50% SOLUTION 100 ML, 300 ML, 400 ML, 500 ML, 600 ML; DMSO W/LIDOCAINE 50%/0.5% SOLUTION 100 ML, 1200 ML, 150 ML, 200 ML, 250 ML, 2500 ML, 30 ML, 300 ML, 400 ML, 50 ML, 500 ML, 600 ML (32 DIFFERENT PRODUCTS) Rx #'s: 0368127 0368127 0396422 0394589 0389031 0397908 0405717 0377092 0395743 0399094 0364766 0377092 0383467 0395743 0399094 0385418 0377092 0391512 0397919 0409221 0395743 0383467 0410209 0353611 0397908 0409800 0372333 0381650 0388770 0357605 0399192 0357605 0357605 0399192 0357605 0370950 0384873 0389326 0357967 0399100 0356533 0361811 0368706 0392087 0401999 0402000 0402006 0405708 0408219 0361811 0368706 0371146 0379509 0380104 0384873 0393576 0403473 0405271 0405527 0371848 0388317 0399025 0408772 0398966 0398276 0352407 0371146 0375451 0377804 0383961 0384873 0388317 0391725 0392087 0393569 0396968 0371146 0375451 0368706 0399665 0401355 0402666 0407936 0362282 0388317 0368311 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 107 units D-1505-2012
DMPS 250MG/10ML INJECTABLE 20 ML, 30 ML; DMPS 50MG/ML (500MG/10ML) INJECTABLE 10 ML, 5 ML (4 DIFFERENT PRODUCTS) Rx #'s: 0405733 0353173 0349837 0392673 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 6 units D-1504-2012
DIPHENHYDRAMINE 25MG/ML INJECTABLE 90 ML; DIPHENHYDRAMINE 50MG/ML INJECTABLE 10 ML, 100 ML, 108 ML, 120 MLS, 25 ML, 32 ML, 60 ML, 90 ML, 90 MLS; DIPHENHYDRAMINE, SDV, 25X1ML** 50MG/ML INJECTABLE 25 ML (11 DIFFERENT PRODUCTS) Rx #'s: 0387528 0395197 0389191 0390909 0406810 0409865 0388591 0388594 0388595 0388597 0388598 0388599 0388602 0388604 0391126 0390909 0390909 0397860 0400856 0402992 0404849 0406843 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 26 units D-1503-2012
DICLOFENAC SODIUM, SDPF - (0.1ML SYRINGE, 30G, 1/2") 500MCG/0.1ML INJECTABLE 0.5 ML, 2 ML, 4 ML (3 DIFFERENT PRODUCTS) Rx #'s: 0392224 0378833 0402369 0360916 0402369 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 5 units D-1502-2012
DIAZEPAM (IM/IV) 1MG/ML INJECTABLE 40 ML, 60 ML; DIAZEPAM (IM/IV) 5MG/ML INJECTABLE 2 ML, 20 ML, 300 ML; DIAZEPAM 2.5MG/ML INJECTABLE 40 ML; DIAZEPAM 2MG/ML INJECTABLE 100 ML, 50 ML (8 DIFFERENT PRODUCTS) Rx #'s:C0406509 C0404925 C0405367 C0399957 C0399948 C0398336 C0403450 C0405679 C0409032 C0398683 C0399922 C0404944 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 13 units D-1501-2012
DEXTROSE/PROCAINE HCL P.F. 12%/1% INJECTABLE 400 ML ( 1 PRODUCT) Rx #: 0395208 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 1 unit D-1500-2012
BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.17% / 0.67% / 2.7% INJECTABLE 15 ML, 18.75 ML, 26.25 ML, 37.5 ML, 45 ML; BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.22% / 0.88% / 0.88% INJECTABLE 450 ML, 900 ML (7 DIFFERENT PRODUCTS) Rx #'s: 0383652 0383653 0383653 0383652 0383652 0383651 0383651 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 7 units D-1477-2012
BUPIVACAINE/LIDOCAINE 0.11% / 0.44% INJECTABLE 150 ML (1 PRODUCT) Rx #: 0386455 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 1 unit D-1476-2012
BUPIVACAINE/HYDROMORPHONE, P.F. 15MG/40MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 22MG/30MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 7.5MG/20MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 7.5MG/25MG/ML INTRATHECAL 18 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 7.5MG/50MG/ML INTRATHECAL 18 ML, 40 ML (6 DIFFERENT PRODUCTS) Rx #'s:N0408787 N0390587 N0391850 N0397485 N0403240 N0387609 N0393487 N0393643 N0403803 N0388585 N0393489 N0401153 N0387605 N0405433 N0408195 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 15 units D-1475-2012
BUPIVACAINE/FENTANYL IN SODIUM CHLORIDE 0.9% P. F. 30 MG/200 MCG/ML INTRATHECAL 40 ML (1 PRODUCT) Rx #'s:N0391834 N0401851 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 2 units D-1474-2012
BUPIVACAINE/CLONIDINE/MORPHINE/ZICONOTIDE, P.F. 20MG/400MCG/20MG/1.5MCG/ML INTRA 20 ML (1 PRODUCT) Rx #:N0408712 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 1 unit D-1473-2012
BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 20MG/400MCG/20MG/ML INTRATHECAL 20 ML (1 PRODUCT) Rx #'s:N0397554 N0402371 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 2 units D-1472-2012
BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 20MG/400MCG/2MG/ML INTRATHECAL; BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 7.5MG/1.5MCG/50MG/ML INTRATHECAL; BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 5MG/500MCG/50MG/ML INTRATHECAL (4 DIFFERENT PRODUCTS) Rx #'s:N0388659 N0392060 N0406634 N0406913 N0397272 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 5 units D-1471-2012
BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.25% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.5% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL 0.25% INJECTABLE 120 ML,180 ML, 240 ML, 250 ML, 300 ML, 500 ML, 60 ML; BUPIVACAINE HCL 0.5% INJECTABLE1000 ML, 120 ML, 200 ML, 250 ML, 400 ML, 50 ML, 500 ML, 600 ML, 750 ML; BUPIVACAINE HCL, P.F. 0.25% INJECTABLE 1000 ML, 120 ML, 1200 ML, 150 ML, 1500 ML, 180 ML, 240 ML, 300 ML, 60 ML, 600 ML, 900 ML; BUPIVACAINE HCL, P.F. 0.5% INJECTABLE 10 ML, 120 ML, 1500 ML, 20 ML, 200 ML, 240 ML, 2500 ML, 300 ML, 360 ML, 600 ML, 960 ML; BUPIVACAINE HCL, P.F. 0.75% INJECTABLE 1200 ML, 150 ML, 240 ML, 30 ML, 600 ML, 7 ML (47 DIFFERENT PRODUCTS) Rx #'s: 0402964 0402963 0398083 0398557 0398524 0406883 0396497 0401829 0407441 0408458 0408393 0398196 0398084 0405518 0397074 0401694 0401412 0398196 0404325 0397888 0407444 0408529 0408099 0401897 0402614 0405996 0402614 0405382 0398014 0398022 0400197 0400116 0400197 0401897 0405996 0398014 0402614 0398014 0401755 0401755 0404391 0402616 0401688 0398026 0399744 0402617 0398026 0401755 0398026 0402616 0400850 0404643 0408996 0403960 0400509 0400960 0403759 0404643 0405771 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 79 units D-1470-2012
BUDESONIDE (P.F) NASAL IRRIGATION 0.5MG/500ML SOLUTION 1000 ML; BUDESONIDE (P.F) NASAL IRRIGATION 0.6MG/50ML SOLUTION 1500 ML (2 DIFFERENT UNITS) Rx #'s: 0390774, 0392517 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 2 units D-1469-2012
BRILLIANT BLUE G, P.F. 0.025% OPHTHALMIC 10 ML, 20 ML, 26 ML, 4 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 0.25MG/ML OPHTHALMIC 2 ML, 2.5 ML, 5 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 0.5MG/ML OPHTHALMIC 1.5 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 1% OPHTHALMIC 0.5 ML,1 ML,1.5 ML, 2 ML, 3 ML, 5 ML, 6 ML, 8 ML; BRILLIANT BLUE G, P.F. (STSL) (0.5ML SYRINGE) 0.025% OPHTHALMIC 2.5 ML, 5 ML; BRILLIANT BLUE G, P.F. (STSL) (0.5ML SYRINGE) 0.15% OPHTHALMIC 2.5 ML; BRILLIANT BLUE G, P.F. 0.25% OPHTHALMIC 1 ML, 10 ML, 20 ML; BRILLIANT BLUE G, P.F. 0.5% OPHTHALMIC 1 ML, 10 ML, 20 ML, 5 ML; BRILLIANT BLUE G, P.F. 1% OPHTHALMIC 10 ML, 12 ML, 15 ML, 2 ML, 2 MLS, 20 ., 20 ML, 30 ML, 4 ML, 40 ML, 50 ML, 6 ML, 80 ML, 9 ML; BRILLIANT BLUE G, P.F. 2% OPHTHALMIC 11 MLS, 15 MLS (43 DIFFERENT PRODUCTS) Rx #'s: 0387683 0393065 0394633 0385938 0387683 0385222 0394375 0389789 0394526 0391261 0399698 0380189 0387389 0384308 0387389 0390830 0370011 0386507 0394133 0397580 0386507 0393521 0374071 0396478 0360399 0377887 0382420 0360399 0382420 0373839 0373839 0367517 0395929 0396303 0398978 0398980 0398983 0398987 0398061 0395908 0366449 0366449 0385953 0395908 0368413 0386587 0387945 0388529 0388631 0390720 0392250 0393056 0395446 0397146 0397459 0399806 0354531 0397967 0399668 0387481 0394553 0396177 0398687 0395424 0388631 0369860 0381370 0388529 0388631 0390143 0392319 0392455 0381370 0393958 0393960 0395294 0396324 0397146 0397149 0389458 0390143 0357319 0369209 0389845 0396123 0360125 0366749 0366749 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 107 units D-1468-2012
BORON 2MG/ML INJECTABLE 40 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0383013, 0383013 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 2 units D-1467-2012
BIEST(80/20) 6.25MG/GM (1.25MG/0.2ML) I-CREAM 6 ML (5 DIFFERENT PRODUCTS) Rx #: 0392274 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 7 units D-1465-2012
BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/100MG/ML INJECTABLE 0.72 ML; BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/20MG/ML INJECTABLE 3 ML, 4.5 ML; BEVACIZUMAB & DXM, SDPF - (0.075ML SYRINGE, 30G, 1/2") 25MG/20MG/ML INJECTABLE 0.225 ML; BEVACIZUMAB & DXM, SDPF - (0.07ML SYRINGE, 30G, 1/2") 25MG/20MG/ML INJECTABLE 0.07 ML, 1.33 ML, 1.4 ML, 1.47 ML; BEVACIZUMAB & DXM, SDPF - (0.07ML SYRINGE, 30G, 1/2") 25MG/40MG/ML INJECTABLE 0.35 ML, 0.7 ML, 1.05 ML; BEVACIZUMAB & DXM, SDPF - (0.07ML SYRINGE, NO NEEDLE) 25MG/40MG/ML INJECTABLE 0.63 ML; BEVACIZUMAB & DXM, SDPF - (0.09ML SYRINGE, 30G, 1/2") 25MG/20MG/ML INJECTABLE 1.8 ML, 2.7 ML; BEVACIZUMAB & DXM, SDPF - (0.09ML SYRINGE, 31G, 5/16") 25MG/20MG/ML INJECTABLE 0.18 ML, 0.27 ML, 0.45 ML, 1.08 ML, 13.5 ML,2.25 ML, 4.5 ML; BEVACIZUMAB & DXM, SDPF - (0.1ML SYRINGE, 30G, 1/2") 25MG/16MG/ML INJECTABLE 0.3 ML, 0.4 ML, 0.5 ML, 1 ML, 1.2 ML, 1.5 ML, 2 ML, 2.5 ML, 5 ML, 7.5 ML; BEVACIZUMAB & DXM, SDPF - (0.1ML SYRINGE, 30G, 1/2") 25MG/40MG/ML INJECTABLE 4 ML, 6 ML; BEVACIZUMAB & DXM, SDPF - (0.1ML SYRINGE, 31G, 5/16") 25MG/16MG/ML INJECTABLE 2 ML, 2.5 ML; BEVACIZUMAB & DXM, SDPF - (0.1ML SYRINGE, 31G, 5/16") 25MG/20MG/ML INJECTABLE 0.3 ML, 0.4 ML, 0.5 ML, 0.6 ML, 0.7 ML, 0.8 ML, 1 ML, 1.5 ML, 55.1 ML, 57.5 ML, 57.6 ML, 58 ML, 7.5 ML; BEVACIZUMAB & DXM, STSL (0.1ML SYRINGE, 30G, 1/2") 25MG/16MG/ML INJECTABLE 0.3 ML; BEVACIZUMAB & TMC, SDPF - (0.075ML SYRINGE, 30G 1/2") 25MG/40MG/ML INJECTABLE 0.075 ML, 0.15 ML, 0.225 ML, 0.375 ML, 0.75 ML, 1.125 ML, 1.5 ML; BEVACIZUMAB & TMC, SDPF (0.075ML SYRINGE, 30G, 1/2") 25MG/80MG/ML INJECTABLE 0.45 ML, 0.75 ML; BEVACIZUMAB & TMC, SDPF - (0.1ML SYRINGE, 30G, 1/2") 25MG/40MG/ML INJECTABLE 0.3 ML, 0.5 ML, 1 ML, 2 ML, 2.5 ML, 3 ML; BEVACIZUMAB & TMC, SDPF - (0.1ML SYRINGE, NO NEEDLE) 25MG/40MG/ML INJECTABLE 0.5 ML; BEVACIZUMAB & TMC, SDPF W/ STSL - (0.075ML SYRINGE, 30G, 1/2") 25MG/80MG/ML INJE 0.375 ML, 0.525 ML, 0.75 ML, 1.125 ML; BEVACIZUMAB & TMC, SDPF W/ STSL - (0.15ML SYRINGE, 30G, 1/2") 25MG/40MG/ML INJEC 0.6 ML, 0.75 ML, 0.9 ML, 1.05 ML; BEVACIZUMAB & TMC, SDPF W/ STSL - (0.1ML SYRINGE, 30G, 1/2") 25MG/20MG/ML INJECT 0.2 ML, 0.4 ML; BEVACIZUMAB & TMC, SDPF W/ STSL - (0.1ML SYRINGE, 30G, 1/2") 25MG/40MG/ML INJECT 0.6 ML, 1 ML; BEVACIZUMAB IN ARTIFICIAL TEARS 0.5% (5MG/ML) OPHTHALMIC 5 ML; BEVACIZUMAB, SDPF - (0.05ML SYRINGE, 27G, 1/2") 25MG/ML INJECTABLE 0.3 ML; BEVACIZUMAB, SDPF - (0.05ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 0 MLS, 0.05 ML, 0.1 ML, 0.15 ML, 0.2 ML, 0.2 MLS, 0.25 ML, 0.25 MLS, 0.3 ML, 0.3 MLS, 0.35 ML, 0.36 ML, 0.4 ML, 0.45 ML, 0.5 ML, 0.6 ML, 0.65 ML, 0.7 ML, 0.75 ML, 0.8 ML, 1 ML, 1.2 ML, 1.25 ML, 1.5 ML,1.5 MLS, 1.75 ML, 1.8 ML, 10 ML, 15 ML, 2 ML, 2.25 ML, 2.5 ML, 2.5 MLS, 2.55 ML, 2.6 ML, 3 ML, 3.1 ML, 3.5 ML, 3.6 ML, 3.65 ML, 3.7 ML, 3.75 ML, 3.96 MLS, 4 ML, 4.5 ML, 5 ML, 5 MLS, 7 ML, 7.2 ML, 7.2 MLS, 7.25 ML, 7.3 MLS, 7.3 VIAL, 7.4 MLS, 7.5 ML; BEVACIZUMAB, SDPF - (0.05ML SYRINGE, 31G, 5/16") 25MG/ML INJECTABLE 0.1 ML, 0.15 ML, 0.2 ML, 0.25 ML, 0.3 ML, 0.35 ML, 0.4 ML, 0.5 ML, 0.55 ML, 0.6 ML, 0.65 ML, 0.7 ML, 0.75 ML, 0.8 ML, 0.85 ML, 0.9 ML, 1 ML, 1.1 ML, 1.2 ML, 1.25 ML, 1.5 ML, 1.75 ML, 10 ML, 12.25 ML, 12.5 ML, 13.5 ML, 15 ML, 17.5 ML, 2 ML, 2.25 ML, 2.5 ML, 2.6 ML, 3 ML, 3.5 ML, 3.75 ML, 4 ML, 4.5 ML, 5 ML, 5.05 ML, 6 ML, 6.25 ML, 6.35 ML, 7.5 ML, 8.75 ML; BEVACIZUMAB, SDPF - (0.06ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 1.2 ML, 2.88 ML; BEVACIZUMAB, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/ML INJECTABLE 1.5 ML, 1.8 ML, 2.4 ML, 3 ML, 3.6 ML, 4.8 ML, 6 ML; BEVACIZUMAB, SDPF - (0.07ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 1.75 ML; BEVACIZUMAB, SDPF - (0.07ML SYRINGE, 31G, 5/16") 25MG/ML INJECTABLE 0.14 ML, 0.21 ML, 1.75 ML, 3.5 ML, 4.2 ML, 5.6 ML, 7 ML; BEVACIZUMAB, SDPF - (0.08ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 0.08 ML; BEVACIZUMAB, SDPF - (0.08ML SYRINGE, NO NEEDLE) 25MG/ML INJECTABLE 0.08 ML, 0.16 ML, 0.24 ML, 0.32 ML, 0.48 ML, 16 ML, 8 ML; BEVACIZUMAB, SDPF - (0.12ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 1.08 ML, 1.2 ML, 1.8 ML, 3.6 ML; BEVACIZUMAB, SDPF - (0.12ML SYRINGE, NO NEEDLE) 25MG/ML INJECTABLE 12 ML, 18 ML, 19.2 ML, 20.4 ML, 22.2 ML, 24 ML, 6 ML, 9 ML, 9.6 ML; BEVACIZUMAB, SDPF - (0.16ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 3.2 ML, 4.8 ML; BEVACIZUMAB, SDPF - (0.1ML SYRINGE, 27G, 1/2") 25MG/ML INJECTABLE 2.5 ML, 3 ML, 3.5 ML, 4 ML, 5 ML, 5.5 ML; BEVACIZUMAB, SDPF - (0.1ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 0.1 ML, 0.2 ML, 0.3 ML, 1 ML, 2 ML, 3 ML, 4 ML; BEVACIZUMAB, SDPF - (0.1ML SYRINGE, 31G 5/16") 25MG/ML INJECTABLE 0.1 ML, 0.6 ML, 1 ML; BEVACIZUMAB, SDPF - (0.1ML SYRINGE, NO NEEDLE) 25MG/ML INJECTABLE 0.5 ML, 2 ML, 3 ML; BEVACIZUMAB, STSL - (0.05ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 0.05 ML, 0.25 ML, 0.5 ML, 0.6 ML, 0.8 ML, 0.95 ML,1 ML, 1.05 ML, 1.2 ML, 1.25 ML, 1.5 ML, 1.8 ML, 1.9 ML, 10 ML, 2 ML, 2.05 ML, 2.25 ML, 3 ML, 3.5 ML, 4 ML, 5 ML; BEVACIZUMAB, STSL - (0.05ML SYRINGE, 30G, 3/8") 25MG/ML INJECTABLE 1 ML, 1.05 ML, 1.5 ML; BEVACIZUMAB, STSL - (0.05ML SYRINGE, 31G, 5/16") 25MG/ML INJECTABLE 0.05 ML, 0.1 ML, 0.15 ML, 0.5 ML, 0.6 ML, 0.75 ML, 1 ML, 1.05 ML, 1.2 ML, 1.25 ML, 1.5 ML, 2 ML, 2.5 ML, 2.75 ML, 3 ML, 3.15 ML, 3.75 ML, 5 ML, 5.5 ML, 6.5 ML, 7.5 ML; BEVACIZUMAB, STSL - (0.1ML SYRINGE, NO NEEDLE) 25MG/ML INJECTABLE 1.2 ML, 1.5 ML, 1.8 ML, 2.1 ML, 2.4 ML (297 DIFFERENT PRODUCTS) Rx #'s: 0359160 0405079 0364389 0364389 0361241 0377683 0377683 0377683 0377683 0401661 0401661 0401661 0390308 0359300 0404762 0382630 0407996 0361441 0407996 0387326 0398781 0356812 0398781 0356812 0375792 0403341 0375792 0399708 0387144 0399708 0387144 0375792 0353919 0375792 0389701 0357461 0387144 0389701 0397437 0352503 0357461 0377580 0377580 0386958 0386958 0367201 0371279 0371279 0367201 0384322 0371279 0384322 0367201 0384322 0384322 0375486 0375486 0375486 0375486 0390996 0381779 0361290 0391677 0403321 0361290 0403321 0397396 0393484 0401740 0390929 0393759 0384195 0388799 0388805 0393759 0388805 0393484 0387836 0387836 0398119 0350119 0359128 0400639 0353914 0394457 0353914 0382205 0353914 0394457 0382205 0393293 0393299 0393300 0399578 0399598 0390926 0393485 0388801 0393485 0388806 0368969 0368969 0390918 0390918 0390918 0392167 0357998 0402352 0393760 0393760 0356752 0401186 0369338 0380167 0367010 0369225 0384207 0385361 0387698 0394363 0395273 0396614 0398024 0398662 0399938 0403502 0408817 0359129 0367010 0367401 0370758 0370759 0370763 0370767 0370768 0370770 0370778 0370779 0370783 0370785 0374018 0374024 0374028 0374036 0379772 0379773 0379774 0387698 0388817 0396342 0407944 0407945 0407946 0408269 0408741 0408742 0408817 0370141 0370142 0371173 0371773 0373627 0376439 0378889 0378890 0378892 0378894 0378897 0378898 0378899 0382662 0382666 0382667 0382669 0382670 0382674 0382919 0383307 0383314 0383346 0385937 0388305 0396302 0399567 0401360 0407944 0407945 0407946 0407948 0407951 0407955 0408233 0408237 0408242 0408248 0408250 0408251 0408259 0408262 0408264 0408265 0408271 0408272 0408274 0408280 0408281 0408284 0408672 0408673 0408674 0408675 0408676 0408677 0408678 0408679 0408680 0408681 0408682 0408683 0408684 0408685 0409171 0409173 0409188 0409191 0409205 0409207 0409825 0409826 0409827 0409828 0409829 0409830 0409831 0352123 0359738 0376439 0384103 0385937 0388817 0401360 0401986 0367896 0355412 0359738 0360220 0371173 0372305 0372673 0375789 0378673 0388774 0391407 0392221 0396687 0400615 0404394 0409879 0409880 0367896 0354585 0372673 0375616 0376439 0377592 0380869 0388817 0389473 0390204 0391693 0392559 0396781 0397261 0397948 0398535 0399761 0401997 0367896 0349959 0350509 0365293 0367347 0369312 0371910 0372413 0373066 0373071 0375917 0375918 0376390 0378853 0385894 0387469 0387471 0387472 0388125 0388126 0388128 0388133 0388136 0388635 0389211 0389215 0390369 0390839 0390843 0390848 0391153 0391338 0391340 0391763 0391764 0391861 0391864 0392979 0393223 0394391 0394393 0394501 0394502 0394707 0395314 0395316 0396363 0396818 0396827 0396829 0397889 0397893 0398006 0398551 0398553 0399238 0399240 0399488 0399489 0399502 0399891 0399892 0399893 0399894 0401526 0401528 0402863 0403606 0403609 0403611 0403785 0404539 0404540 0405532 0405933 0406247 0375916 0366046 0366486 0378138 0380869 0386460 0388817 0394444 0398535 0401997 0409796 0378138 0398535 0354936 0355412 0359129 0359985 0360220 0363258 0365502 0367016 0367501 0368624 0371173 0372081 0373976 0375616 0377592 0378673 0382974 0383654 0386404 0387739 0388288 0388774 0388785 0389473 0389828 0392521 0392818 0394444 0398535 0402803 0403654 0404459 0405383 0408232 0409453 0350698 0355237 0366486 0368624 0371173 0378138 0384670 0385775 0388288 0391887 0393789 0396687 0388817 0366486 0356702 0359129 0360220 0367016 0375789 0378673 0382974 0384849 0386404 0387740 0388288 0389473 0390219 0397948 0398337 0398805 0354554 0359129 0388817 0352916 0352996 0354554 0359129 0359985 0361041 0362197 0363258 0365502 0366486 0367016 0367240 0368282 0368624 0371184 0375789 0378583 0378823 0379513 0380679 0382974 0383438 0384676 0384849 0386729 0387024 0387168 0387740 0388154 0388785 0389511 0391887 0392445 0393797 0399912 0400472 0400522 0401225 0405018 0409004 0409245 0379513 0385775 0352372 0361666 0365188 0365502 0366619 0368282 0378583 0378911 0382974 0385549 0387024 0387374 0387420 0389828 0392938 0394683 0397164 0405238 0408232 0349177 0350459 0352916 0354764 0358804 0359985 0363966 0368493 0371184 0378583 0380167 0385014 0385036 0385549 0387024 0387168 0387334 0387374 0387739 0388080 0388154 0388288 0388561 0389828 0390176 0390219 0391013 0392187 0392445 0393559 0394572 0398217 0401225 0402280 0403944 0405665 0407685 0409157 0380167 0354764 0378583 0387024 0387374 0398602 0379513 0390966 0382620 0390262 0390262 0350302 0357190 0360145 0366591 0378823 0380999 0383438 0384207 0384676 0384713 0385014 0385036 0387024 0387739 0388561 0391007 0391265 0391768 0398602 0407622 0409004 0376772 0406033 0351645 0353827 0355623 0360220 0360607 0361078 0361666 0363966 0366600 0366619 0368316 0378911 0380061 0380658 0384676 0384713 0384923 0387739 0390060 0390223 0390262 0392818 0395368 0397164 0398337 0399928 0402827 0405238 0408166 0408815 0380323 0387420 0380061 0353827 0355819 0357190 0361868 0366591 0373924 0378823 0380999 0383438 0387168 0392868 0395368 0399063 0400380 0405406 0408666 0409004 0361868 0353827 0365737 0365737 0389735 0365737 0365737 0380167 0361666 0387815 0380167 0357190 0373924 0380999 0388167 0387488 0352821 0352950 0354664 0365296 0366374 0373924 0380658 0384676 0384923 0385412 0386588 0388167 0390060 0390223 0390262 0394454 0394514 0396082 0399081 0380323 0364967 0399540 0402861 0373924 0380167 0380167 0380167 0380167 0380167 0365296 0386588 0408941 0391001 0396063 0396064 0396069 0396072 0396074 0396076 0406966 0367119 0367128 0367144 0367162 0367167 0367168 0368589 0368907 0370072 0370538 0371351 0373487 0376100 0376101 0376102 0376108 0377388 0377390 0377391 0377639 0378635 0378637 0384407 0400209 0408467 0408474 0408482 0408922 0408924 0408926 0408945 0408955 0408957 0408958 0408959 0408960 0408963 0408965 0408968 0408969 0408971 0408973 0408975 0408976 0408979 0408981 0408982 0408985 0408986 0408988 0409360 0409362 0409363 0409365 0409367 0409368 0409370 0409371 0409455 0409456 0409460 0409462 0409466 0409467 0409469 0409470 0409473 0409474 0409475 0409476 0409478 0409479 0409480 0409481 0409482 0409483 0409485 0409486 0409992 0409995 0409996 0409997 0410009 0379496 0379497 0382688 0384407 0394883 0394892 0394894 0367009 0371356 0379346 0384407 0387817 0367009 0395420 0380864 0362676 0391416 0360422 0367009 0368228 0371356 0379166 0379346 0380864 0382774 0386513 0388038 0389912 0390124 0391416 0394138 0400209 0404461 0380864 0368228 0384722 0387051 0380864 0380864 0350991 0357056 0361676 0365399 0367009 0368228 0377761 0380864 0384722 0386513 0390124 0394138 0394380 0394654 0368228 0380864 0404786 0390124 0387051 0349046 0349527 0352252 0360448 0364804 0365399 0366800 0368585 0371356 0372632 0375719 0377761 0379346 0380567 0380758 0380864 0381539 0384722 0387508 0387817 0389697 0389912 0390124 0390147 0392169 0393206 0393526 0394312 0394380 0394654 0396688 0402930 0404374 0393206 0387051 0391416 0392169 0363706 0364338 0371356 0382947 0384722 0392169 0406187 0407176 0349333 0362957 0363706 0368581 0370372 0371356 0377761 0380754 0381076 0382339 0384722 0388038 0389046 0390124 0391060 0392169 0393761 0394015 0394312 0396688 0406070 0380505 0389046 0354566 0356480 0358943 0373161 0399623 0391272 0399623 0391272 0385261 0386746 0385261 0363706 0366800 0366802 0368581 0368585 0371356 0380754 0381539 0382339 0388038 0388856 0389371 0390147 0393761 0394312 0398208 0380505 0398208 0363706 0363778 0364338 0366802 0368581 0369332 0378667 0381748 0382339 0385261 0388038 0388530 0388856 0389697 0403307 0405316 0408287 0388856 0361320 0363706 0366802 0381076 0404496 0366802 0381076 0363706 0369332 0381076 0381748 0406528 0389697 0370372 0358943 0368879 0369332 0370372 0378279 0386285 0386631 0387440 0389697 0401843 0406187 0409595 0386285 0386631 0368879 0366903 0401843 0378279 0356077 0358943 0366903 0367878 0378279 0399290 0358943 0366903 0373461 0386366 0391318 0386239 0386239 0391318 0369515 0381033 0399529 0381033 0369515 0382083 0408575 0410038 0408545 0408548 0408549 0408551 0408552 0408556 0408557 0408559 0408561 0408562 0408563 0408564 0408566 0408567 0408568 0408572 0410000 0410003 0410005 0410006 0410010 0410011 0410012 0410013 0410014 0410021 0410023 0410026 0410027 0410032 0410035 0410036 0384698 0374276 0384698 0359109 0359109 0385519 0357253 0369326 0371914 0379256 0362070 0389165 0389174 0389559 0390877 0406656 0375624 0389043 0390877 0395563 0398015 0402663 0405680 0409170 0409331 0360751 0363002 0375624 0389165 0389469 0390962 0392527 0393758 0395160 0395382 0396588 0396772 0397371 0406507 0407078 0410316 0349549 0354136 0392052 0392052 0386359 0391609 0391609 0384742 0390822 0390822 0390822 0385919 0385919 0385919 0390822 0390822 0401752 0401752 0389208 0389208 0353398 0353398 0395793 0395793 0395793 0395793 0408132 0362868 0362868 0408092 0408098 0408104 0408106 0408108 0408109 0408112 0408121 0408123 0408125 0408126 0408127 0408131 0408270 0388851 0390649 0401777 0356392 0380680 0388851 0400670 0384734 0386866 0367047 0367047 0368258 0387412 0387412 0389503 0406922 0366709 0384829 0366709 0384845 0357997 0389503 0366709 0389503 0390475 0406922 0402353 0384845 0386279 0387641 0360671 0389503 0387641 0368967 0361445 0405294 0368967 0387641 0389503 0389503 0368967 0369511 0386279 0393604 0369511 0369511 0393604 0361445 0390391 0390391 0391674 0367965 0374654 0379809 0379812 0379814 0379823 0388302 0388304 0394315 0394316 0394317 0394318 0394319 0394320 0394321 0394322 0394323 0394324 0394325 0394326 0394327 0394328 0394329 0394330 0394331 0394334 0394335 0394336 0394337 0396752 0396755 0396757 0396760 0396761 0396786 0396788 0396791 0396795 0396796 0396799 0396800 0396811 0396812 0396819 0396832 0396834 0396838 0396839 0401284 0401285 0401286 0401287 0401288 0401289 0401290 0401291 0401292 0401293 0401294 0401295 0401296 0401308 0401309 0401311 0401314 0401315 0403881 0403882 0403884 0403885 0403886 0403887 0403888 0403890 0403891 0403892 0403893 0403894 0403895 0403896 0403897 0403898 0403901 0403902 0403903 0403904 0403905 0403907 0403908 0403909 0403910 0409124 0409125 0409126 0409127 0409129 0409131 0379823 0396780 0396793 0396809 0396831 0402979 0404976 0393055 0402979 0358989 0365946 0399776 0404124 0408612 0358989 0360992 0360992 0402979 0360992 0402979 0392886 0353140 0360992 0393055 0360992 0392202 0355828 0377903 0355828 0393055 0393439 0409335 0393439 0351750 0353140 0355822 0355821 0355822 0355828 0392202 0355903 0355821 0355821 0366633 0392219 0392219 0392219 0366633 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 2350 units D-1464-2012
BACLOFEN/MORPHINE, P.F. 1,000MCG/25MG/ML INTRATHECAL 18 ML; BACLOFEN/MORPHINE, P.F. 1,500MCG/1.5MG/ML INTRATHECAL 40 ML; BACLOFEN/MORPHINE, P.F. 2,000MCG/25MG/ML INTRATHECAL 40 ML (3 DIFFERENT PRODUCTS) Rx #'s:N0392050, N0391605, N0402936 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 3 units D-1462-2012
BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/2.9MG/ML INTRATHECAL 20 ML; BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/6MG/ML INTRATHECAL 40 ML; BACLOFEN/HYDROMORPHONE, P.F. 500MCG/50MG/ML INTRATHECAL 40 ML (2 DIFFERENT PRODUCTS) Rx #'s:N0407992, N0387607, N0394440, N0402003, N0409979, N0399632 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 6 units D-1461-2012
BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 1000MCG/7.5MG/1000MCG/50MG/ML INTR 40 ML; BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 50MCG/2MG/200MCG/50MG/ML INTRATHEC 18 ML; BACLOFEN/CLONIDINE/BUPIVACAINE/MORPHINE, P.F. 500MCG/1/7.5/50MG/ML INTRATHECAL 40 ML (3 DIFFERENT PRODUCTS) Rx #'s:N0406290, N0387600, N0390988, N0393344, N0396645, N0400013, N0403729, N0406665, N0410203, N0393490 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 10 units D-1460-2012
BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 2,000MCG/ML (2MG/ML) INTRATHECAL 40 ML; BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 600MCG/ML INTRATHECAL 40 ML; BACLOFEN, P.F. 1,000MCG/ML (1MG/ML) INTRATHECAL 20 ML, 40 ML; BACLOFEN, P.F. 500MCG/ML (0.5MG/ML) INTRATHECAL 40 ML; BACLOFEN, PRESERVATIVE FREE 3000MCG/ML INJECTABLE 40 ML; BACLOFEN, PRESERVATIVE FREE 3300MCG/ML(3.3MG/ML) INTRATHECAL 20 ML; BACLOFEN, PRESERVATIVE FREE 5000MCG/ML(5MG/ML) INTRATHECAL 40 ML (8 DIFFERENT PRODUCTS) Rx #'s: 0406446, 0404313, 0381309, 0390603, 0350228, 0389240, 0365111, 0383582, 0391840, 0399130, 0372385, 0387886, 0406914 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 21 units D-1459-2012
ATROPINE SULFATE 0.4MG/ML INJECTABLE 12 ML, 2 ML, 20 ML, 24 ML, 25 ML, 3 ML; ATROPINE/EPINEPHRINE/ BSS 0.02MG/0.1MG/ML INJECTABLE 10 ML, 5 ML (8 DIFFERENT PRODUCTS) Rx #'s: 0398523, 0404345, 0404347, 0404348, 0404349, 0404351, 0406460, 0384921, 0395199, 0399779, 0379708, 0395199, 0389329, 0409506, 0378436 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 32 units D-1458-2012
ASCORBIC ACID (BEET SOURCE) 500MG/ML INJECTABLE 100 ML, 150 ML, 200 ML, 250 ML, 300 ML, 400 ML, 500 ML, 60 ML; ASCORBIC ACID (CORN SOURCE) 500MG/ML INJECTABLE 100 ML; ASCORBIC ACID, 50ML SDPF, VIAL** 500MG/ML INJECTABLE 50 ML, 500 ML; ASCORBIC/B1/B2/B3/B5/B6/B12/METHIONINE/INOSITOL/CHOLINE/LIDO INJECTABLE 40 ML, 50 ML, 60 ML (14 DIFFERENT PRODUCTS) Rx #'s: 0388808, 0406214, 0388808, 0406214, 0388808, 0388808, 0388808, 0406214, 0400763, 0402158, 0393558, 0393558, 0394256 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 19 units D-1457-2012
AMPHOTERICIN B OPHTHALMIC (0.5ML, LL SYRINGE) P.F. 10MCG/0.1ML INJECTABLE 1 ML, 1.5 ML, 2 ML, 2.5 ML, 5 ML; AMPHOTERICIN B OPHTHALMIC 5MCG/0.1ML INJECTABLE, 0.2 ML, 0.4 ML, 3 ML; AMPHOTERICIN B, LYOPHILIZED 150MCG INJECTABLE 2 VIAL; AMPHOTERICIN-B, NEBULIZATION, STERILE 5MG/2ML NASO-NEB 60 ML (10 DIFFERENT PRODUCTS) Rx #'s: 0404547, 0404385, 0410167, 0410170, 0410171, 0404102, 0404102, 0404547, 0380221, 0373088, 0398747, 0390360, 0402572 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 15 units D-1456-2012
AMINOPHYLLINE 20ML, SDV** 500MG (25MG/ML) INJECTABLE 20 ML (1 PRODUCT) Rx #: 0390157 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 1 unit D-1455-2012
ALTEPLASE, SDPF - (0.05ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.05 ML; ALTEPLASE, SDPF - (0.15ML LL SYRINGE, NO NEEDLE) 100MCG/ML (10MCG/0.1ML) INJECTA 0.15 ML, 0.3 ML; ALTEPLASE, SDPF - (0.1ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.1 ML, 0.2 ML, 0.3 ML; ALTEPLASE, SDPF - (0.1ML SYRINGE, 30G, 1/2") 100MCG/ML (10MCG/0.1ML) INJECTABLE 0.1 ML, 0.3 ML; ALTEPLASE, SDPF - (0.1ML SYRINGE, 30G, 1/2") 250MCG/ML (25MCG/0.1ML) INJECTABLE 0.1 ML (9 DIFFERENT PRODUCTS) Rx #'s: 0392878, 0398614, 0394932, 0394932, 0387461, 0352013, 0391247, 0391792, 0399973, 0401614, 0402893, 0392721, 0392721, 0382234 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. 16 units D-1453-2012
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