FDAFDA · Food and drugs·Recall number D-1629-2012

TRIMIX 9MG / 0.3MG /3.3MCG INJECTABLE 6 ML; TRIMIX 9MG / 0.3MG /6.6MCG INJECTABLE 6 ML; TRIMIX 9MG / 1MG / 10MCG INJECTABLE 10 ML; TRIMIX ((LYOPHILIZED)) - 2ML VIAL 30MG / 1MG / 10MCG INJECTABLE 10 ML 10 VIALS 2 ML 4 ML 50 ML; TRIMIX ((LYOPHILIZED)) - 5ML VIAL 30MG / 2MG / 20MCG INJECTABLE 10 ML; TRIMIX ((LYOPHILIZED)) - 5ML VIAL 30MG / 2MG / 40MCG INJECTABLE 100 ML 5 ML 75 ML; TRIMIX 10MG / 0.5MG / 1MCG INJECTABLE 10 ML; TRIMIX 10MG / 1MG / 5MCG INJECTABLE 10 ML; TRIMIX 10MG/1MG/0.5MCG INJECTABLE 10 ML; TRIMIX 12.5MG/0.83MG/8.33MCG INJECTABLE 10 ML; TRIMIX 12MG / 1MG / 12MCG INJECTABLE 10 ML; TRIMIX 12MG / 1MG / 9MCG INJECTABLE 10 ML 10 MLS 20 ML 30 ML 5 ML; TRIMIX 12MG/1MG/5MCG INJECTABLE 10 ML; TRIMIX 15MG / 1MG / 10MCG INJECTABLE 3 ML 5 ML; TRIMIX 22.5MG/0.83MG/3MCG INJECTABLE 10 ML; TRIMIX 22.5MG/0.83MG/8.33MCG INJECTABLE 1 ML 10 ML 15 ML 2.5 ML 3 ML 30 ML 5 ML; TRIMIX 24MG / 1MG / 10MCG INJECTABLE 10 ML; TRIMIX 24MG / 1MG / 18MCG INJECTABLE 10 ML; TRIMIX 25MG/ 1MG / 10MCG INJECTABLE 10 ML; TRIMIX 28MG / 0.9MG / 37MCG INJECTABLE 5 ML; TRIMIX 30MG / 0.1MG / 40MCG INJECTABLE 10 ML; TRIMIX 30MG / 0.2MG / 10MCG INJECTABLE 10 ML; TRIMIX 30MG / 0.5MG / 10MCG INJECTABLE 10 ML; 120 ML 5 ML 60 MLS; TRIMIX 30MG / 0.5MG / 20MCG INJECTABLE 1.7 ML 10 ML 50 ML; TRIMIX 30MG / 0.5MG / 50MCG/ML INJECTABLE 10 ML; TRIMIX 30MG / 0.5MG / 5MCG INJECTABLE 10 ML 5 ML; TRIMIX 30MG / 10MG / 20MCG INJECTABLE 5 ML; TRIMIX 30MG / 10MG / 60MCG INJECTABLE 10 ML 10 MLS 20 ML 5 ML; TRIMIX 30MG / 1MG / 18MCG INJECTABLE 5 ML; TRIMIX 30MG / 1MG / 2.5MCG INJECTABLE 3 ML 5 ML; TRIMIX 30MG / 1MG / 20MCG INJECTABLE 1 ML 10 ML 10 MLS 3 ML 5 ML; TRIMIX 30MG / 1MG / 30MCG INJECTABLE 10 ML 5 ML; TRIMIX 30MG / 1MG / 40MCG INJECTABLE 10 ML; TRIMIX 30MG / 1MG / 50MCG INJECTABLE 10 ML 10 MLS 100 ML 5 ML; TRIMIX 30MG / 1MG / 5MCG INJECTABLE 10 ML 20 ML 5 ML; TRIMIX 30MG / 2MG / 100MCG INJECTABLE 20 ML; TRIMIX 30MG / 2MG / 10MCG INJECTABLE 10 ML; TRIMIX 30MG / 2MG / 20MCG INJECTABLE 1 ML 10 ML 10 MLS 2 ML 2.5 ML 20 ML 3 ML 5 ML 5 MLS 6 ML 60 ML; TRIMIX 30MG / 2MG / 25MCG INJECTABLE 10 ML; TRIMIX 30MG / 2MG / 30MCG INJECTABLE 10 ML 10 MLS 5 ML; TRIMIX 30MG / 2MG / 3MCG INJECTABLE 5 ML; TRIMIX 30MG / 2MG / 40MCG INJECTABLE 1 ML 1.25 ML 10 ML 15 ML 2 ML 2.5 ML 20 ML 20 MLS 30 ML 4 ML 40 ML 5 ML 6 ML 60 ML; TRIMIX 30MG / 4MG / 3.5MCG INJECTABLE 10 ML

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: 0370964 0392699 0399999 0388807 0373823 0407907 0408836 0409758 0368890 0396425 0404388 0390568 0393084 0390568 0353060 0390096 0369563 0356202 0399491 0377731 0365263 0398599 0400417 0409104 0381235 0355859 0371377 0402545 0371377 0404586 0359139 0375269 0380498 0390885 0371652 0371652 0370384 0390476 0357298 0381009 0389478 0400908 0391406 0388541 0390476 0389352 0403385 0390300 0391406 0380532 0371606 0392256 0364156 0402994 0407589 0369206 0378697 0388874 0391939 0399751 0409764 0357230 0401215 0393374 0401252 0403616 0407339 0381249 0393047 0399227 0373040 0410204 0353362 0367634 0380616 0387463 0395032 0396526 0400059 0403263 0403268 0408301 0385463 0409902 0395126 0399133 0401102 0401107 0401651 0403704 0405197 0405760 0406316 0406322 0396285 0403691 0397249 0359198 0407962 0362367 0403023 0405308 0371668 0351463 0355946 0358970 0367278 0368955 0378244 0378494 0381048 0381893 0382831 0389390 0392285 0392879 0394905 0403994 0358379 0375331 0374070 0398377 0368154 0374011 0376715 0382454 0382831 0399423 0399645 0401306 0391641 0402714 0408696 0394497 0409808 0406673 0375182 0393832 0391683 0368348 0375182 0385666 0391426 0367299 0408918 0360740 0375301 0391074 0392376 0397160 0398142 0399608 0402052 0402492 0377170 0385187 0352706 0355092 0356255 0356732 0358621 0363754 0364595 0365070 0365619 0366077 0367690 0369330 0369413 0369770 0371950 0372657 0373473 0374074 0374392 0374730 0374749 0377455 0378324 0379558 0380891 0381211 0382037 0382046 0382986 0383709 0384705 0385187 0386830 0386838 0386841 0387525 0388003 0388219 0388610 0389400 0389613 0389902 0390005 0390119 0390361 0390416 0390575 0390590 0392011 0393375 0393527 0393802 0393821 0394721 0395123 0395253 0395362 0395619 0396264 0396704 0396920 0397032 0397650 0397679 0397931 0398131 0398331 0398696 0399673 0399676 0399926 0400329 0400747 0400874 0401081 0401356 0401580 0402139 0402289 0402383 0402504 0402543 0403355 0403486 0403789 0403798 0403802 0404070 0404189 0404775 0404793 0405117 0405387 0405403 0405643 0405872 0405918 0406134 0406144 0406252 0406389 0406712 0407038 0407237 0407380 0407464 0407479 0407941 0408051 0408630 0408801 0409019 0409021 0409137 0409248 0409681 0409745 0409918 0353075 0377170 0393821 0398665 0401094 0407571 0366685 0410242 0381447 0382347 0399747 0402383 0367834 0382756 0385041 0406641 0406741 0352749 0362161 0363543 0365973 0366062 0370030 0371579 0373491 0374377 0374749 0375400 0376274 0376650 0377613 0377756 0379507 0379766 0380749 0382500 0384286 0385041 0385187 0386025 0386153 0386315 0386401 0388556 0389501 0389584 0390924 0391308 0391593 0391721 0393171 0393193 0393470 0393669 0393752 0393993 0394102 0394158 0394780 0395464 0396003 0396807 0397514 0397845 0398082 0398120 0398157 0399466
Risk classification: Class II
Area (FDA): drug
Country: United States

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