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U.S. Department of Health and Human Services

Enforcement Report - Week of August 22, 2012

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Product Detail

Product Description 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)
Recall Number D-1466-2012
Classification Class II
Code Info 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
Product Distributed Qty 448 units
Reason For Recall 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.

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
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