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Drug Enforcement D-1629-2012

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.

Status

Terminated

Classification

Class II

Report Date

August 22, 2012

Termination Date

August 15, 2014

Product Information

Product description: 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
Product quantity: 1603 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.
Recall initiation reason: —
Initial firm notification: Letter
Distribution pattern: Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

Location & Firm

Recalling firm: Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Address: 1210 SW 33rd Avenue

United States
Voluntary / Mandated: Voluntary: Firm initiated
Status date: —

Codes & Dates

Recall number: D-1629-2012
Event ID: 62443
Recall initiation date: May 21, 2012
Center classification date: August 10, 2012
Code info: 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 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More code info: —