FDAFDA · Food and drugs·Recall number D-1581-2012
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
Published August 22, 2012 · Recall initiated: May 21, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Distributor
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
- Lot
- 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 0
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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