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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 MITOMYCIN 1MG/ML SOLUTION 160 ML 40 ML 80 ML; MITOMYCIN SOLUTION, STERILE 0.02% (200MCG/ML) OPHTHALMIC 0.5 ML 1 ML 1.5 ML 10 ML 12.5 ML 2 ML 2.5 ML 3 ML 30 ML 4 ML 5 ML 6 ML 7 ML; MITOMYCIN SOLUTION, STERILE 0.025% (250MCG/ML) OPHTHALMIC 2 ML 3 ML 4 ML 6 ML MITOMYCIN SOLUTION, STERILE 0.03% (300MCG/ML) OPHTHALMIC 2 ML 3 ML 4 ML 5 ML; MITOMYCIN SOLUTION, STERILE 0.04% (400MCG/ML) OPHTHALMIC 1 ML 10 ML 12 ML 2 ML 20 ML 3 ML 3.6 ML 4 ML 5 ML 5.4 ML 6 ML 7.2 ML; MITOMYCIN SOLUTION, STERILE 0.05% (500MCG/ML) OPHTHALMIC 1.5 ML 10 ML 15 ML 2 ML 3 ML 5 ML; MITOMYCIN SOLUTION, STERILE/BUFFERED 0.5MG/ML INJECTABLE 80 ML; MITOMYCIN, LYOPHILIZED 1MG INJECTABLE 1 VIAL 10 VIAL 12 VIAL 2 VIAL 2 VIALS 20 VIAL 20 vials 3 VIAL 3 VIALS 4 VIAL 4 VIALS 5 VIAL 5 VIALS 50 VIAL 6 VIAL 6 VIALS 8 VIAL 8 VIALS; MITOMYCIN, LYOPHILIZED (BUFFERED) 20MG INJECTABLE 1 VIAL 10 VIAL 12 VIAL 15 VIAL 16 VIAL 17 VIALS 18 VIAL 2 VIAL 20 VIAL 24 VIAL 24 VIALS 3 VIAL 30 VIAL 4 VIAL 5 VIAL 6 VIAL 6 VIALS 7 VIAL 7 VIALS 8 VIAL 8 VIALS; MITOMYCIN, LYOPHILIZED (BUFFERED) 40MG INJECTABLE 1 VIAL 1 VIALS 10 VIAL 10 VIALS 11 VIAL 12 VIAL 12 VIALS 13 VIAL 14 VIAL 15 `VIAL 15 VIAL 16 `VIAL 16 VIAL 17 `VIAL 18 VIAL 18 VIALS 2 `VIAL 2 VIAL 2 VIALS 20 VIAL 20 vials 23 `VIAL 23 VIAL 24 VIAL 3 VIAL 3 VIALS 30 VIAL 36 VIAL 4 VIAL 4 VIALS 40 VIAL 41 VIAL 5 VIAL 5 VIALS 50 VIAL 6 `VIAL 6 VIAL 6 VIALS 7 VIAL 8 VIAL 8 VIALS 9 VIAL; MITOMYCIN, LYOPHILIZED (BUFFERED) 5MG INJECTABLE 16 VIAL 2 VIAL 36 VIAL 4 VIAL; MITOMYCIN, LYOPHILIZED (OPHTHALMIC USE) 5MG INJECTABLE 4 VIAL 5 VIAL (130 DIFFERENT PRODUCTS)
Recall Number D-1581-2012
Classification Class II
Code Info Rx #'s: 0385634 0395331 0382740 0391178 0392393 0402036 0404974 0406412 0348990 0389957 0389256 0398308 0400088 0402379 0368830 0381744 0391578 0393939 0368830 0394696 0394699 0394702 0400088 0370658 0374176 0374332 0377853 0396389 0409606 0397569 0363591 0363906 0364885 0368563 0370643 0374134 0388160 0390765 0391578 0397626 0397664 0405185 0368830 0390948 0360900 0364885 0370658 0371998 0377418 0386488 0387749 0390765 0391251 0392700 0396481 0404354 0408442 0408450 0384787 0364885 0399054 0399978 0407186 0357229 0368830 0369658 0378021 0388340 0392613 0392899 0395705 0396389 0397569 0398713 0401967 0363906 0369658 0374332 0385847 0395772 0389236 0354926 0372478 0389236 0403647 0369615 0372478 0403647 0398727 0356719 0384919 0358078 0405425 0364078 0361229 0355028 0363367 0387510 0393522 0396503 0396748 0402531 0403762 0381124 0389376 0390757 0397155 0403061 0407722 0402531 0409835 0360794 0367718 0380495 0399205 0392377 0375206 0366326 0389376 0390757 0392377 0375206 0393522 0399205 0406462 0392377 0381206 0379957 0386978 0387228 0381206 0405721 0379957 0386978 0388312 0355234 0395430 0396345 0397113 0397206 0398817 0364094 0390534 0395074 0381540 0355612 0356043 0381225 0389512 0398817 0406027 0398694 0390534 0397464 0356043 0364094 0376377 0390194 0390768 0396674 0402214 0408184 0393442 0364094 0396343 0399934 0379020 0404494 0365952 0385380 0379020 0406986 0363729 0366561 0404494 0371056 0407417 0393442 0392768 0394298 0394606 0397253 0403210 0403347 0406699 0407892 0408311 0355056 0361444 0367534 0367592 0373176 0379506 0388023 0398878 0366168 0367534 0373176 0385023 0389065 0408083 0410227 0367592 0388249 0396642 0398122 0408087 0385991 0367534 0378631 0390829 0392453 0395572 0395650 0395824 0396106 0396417 0399802 0401313 0401636 0407069 0408311 0367592 0405638 0408667 0356337 0387887 0387973 0398326 0354974 0385991 0360653 0368998 0383647 0386367 0401638 0404139 0401960 0352358 0363847 0368488 0376511 0379506 0388170 0394298 0395650 0395898 0396265 0402035 0405424 0388023 0390528 0398974 0363108 0368488 0376484 0377711 0379506 0383647 0383963 0383964 0386977 0389901 0395650 0396106 0397928 0398012 0399791 0400411 0401313 0401367 0404852 0406516 0406559 0409054 0409493 0358706 0366168 0388023 0385991 0356048 0390829 0399052 0404405 0358706 0364163 0368438 0373628 0378415 0380729 0384022 0384820 0384924 0386712 0387628 0387865 0388826 0389073 0390173 0390513 0390518 0390718 0391743 0392014 0394543 0394720 0396104 0396816 0397072 0397419 0399203 0399386 0400178 0401617 0404283 0404700 0407235 0408221 0409542 0395110 0354218 0356050 0356327 0357403 0358003 0358929 0359280 0369134 0369611 0376117 0377566 0383704 0385106 0387713 0387750 0390828 0390946 0391451 0393749 0394531 0395077 0396798 0398991 0399005 0402840 0403368 0403373 0403783 0406711 0378537 0398212 0356050 0359583 0364548 0356679 0357791 0363049 0364936 0367239 0369134 0370023 0373956 0376260 0376320 0378647 0385669 0386712 0386728 0387706 0390516 0390582 0393749 0393750 0395077 0396563 0398214 0399267 0399427 0400465 0403478 0405056 0406904 0408321 0408323 0408782 0408851 0409600 0358139 0361373 0389055 0399571 0386086 0395077 0404402 0409082 0357126 0396419 0395077 0354088 0377073 0385106 0390516 0390582 0394621 0401223 0395077 0391517 0395077 0406365 0395077 0354088 0409434 0395077 0353042 0355236 0355741 0357825 0365251 0372377 0375561 0379898 0382826 0383962 0384022 0384924 0389359 0389743 0390582 0392165 0393457 0394495 0394543 0395134 0395508 0395740 0396450 0396518 0396646 0396816 0398780 0398851 0404013 0404699 0404700 0405413 0408164 0395110 0400486 0408927 0357791 0359618 0364936 0369611 0384820 0387750 0392194 0397577 0399005 0400973 0401482 0408304 0359542 0395077 0395077 0354963 0360217 0391978 0398044 0398667 0404323 0353729 0353865 0354218 0356046 0358187 0359583 0365315 0367667 0371838 0373520 0374413 0375806 0376320 0376927 0381501 0382825 0383066 0383704 0383962 0384465 0385984 0386979 0387539 0387706 0388534 0389466 0389585 0389743 0393457 0394543 0394859 0395508 0395602 0395740 0396518 0399213 0401861 0402198 0404199 0406508 0406659 0407374 0407843 0408383 0409753 0397128 0357793 0363902 0390516 0401223 0401482 0358931 0352357 0355240 0359289 0364548 0364695 0367998 0368184 0372377 0373628 0375378 0378647 0378649 0381501 0384820 0385106 0386086 0386173 0386332 0386979 0388534 0388663 0390218 0390389 0390518 0391172 0391258 0391283 0391296 0391799 0393457 0393749 0395134 0396518 0404013 0404108 0404283 0406982 0407388 0408758 0410018 0378537 0359618 0364730 0371189 0401482 0354088 0359289 0362308 0364163 0368184 0375806 0378415 0381901 0383704 0385106 0387539 0387865 0388534 0388826 0389743 0389810 0390516 0391234 0391743 0392807 0394258 0395128 0396816 0399377 0404013 0405630 0389055 0371189 0394299 0395077 0353449 0353729 0353865 0354732 0354913 0354963 0355240 0355628 0356046 0356304 0357126 0357677 0357888 0359106 0359289 0359341 0359698 0361085 0361327 0362308 0362611 0363049 0364163 0368105 0368438 0371592 0373956 0374017 0375142 0375378 0375766 0375806 0376260 0376927 0378415 0378647 0378649 0381035 0381501 0382827 0385024 0385106 0385448 0385669 0385984 0386080 0386712 0387467 0387539 0387675 0387706 0387871 0389070 0389743 0389850 0390059 0390838 0390945 0391284 0391511 0391628 0391743 0392009 0392097 0392172 0392403 0392406 0392550 0392842 0393749 0394127 0394252 0394258 0394531 0394720 0395038 0395128 0395436 0395721 0396798 0396816 0396879 0396969 0397072 0397171 0397190 0397303 0397645 0398046 0398138 0398139 0398830 0398991 0399028 0399068 0399223 0399377 0400422 0400465 0400634 0400722 0400966 0401243 0401582 0401900 0401938 0402188 0402191 0402209 0403106 0403669 0404199 0404308 0404465 0404524 0404725 0404903 0404964 0405161 0405210 0405908 0406206 0406678 0406982 0407579 0407584 0408199 0408201 0408468 0409075 0409538 0409580 0409589 0409591 0409705 0409844 0409847 0410320 0378537 0388863 0389055 0394218 0399571 0354088 0387539 0399803 0401011 0404283 0352357 0354088 0354238 0355240 0357677 0359106 0359583 0363624 0368996 0369084 0384127 0385106 0386086 0386173 0388309 0388311 0388314 0389238 0392448 0394531 0395128 0396012 0396798 0396934 0398273 0399028 0399036 0400465 0400634 0400641 0400937 0401910 0402479 0402539 0403346 0404741 0405675 0405719 0406900 0407235 0407799 0408746 0408832 0367324 0380605 0388863 0354088 0376320 0378844 0379039 0384820 0385024 0386086 0391531 0394767 0395077 0404308 0390240 0383248 0400817 0383248 0395901 0402029 0388395 0394585 0391474
Product Distributed Qty 1079 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Event Detail

Event Id 62443
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 2012-05-21
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
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