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Recall Observatory FDA recall evidence

Drug product

TRIMIX/LIDOCAINE 11.8MG/0.39MG/10.6MCG/1.7MG/ML INJECTABLE 30 ML; TRIMIX/LIDOCAINE 13.6MG/0.45MG/38.2MCG/7.3MG/ML INJECTABLE 10 ML; TRIMIX/LIDOCAINE 12MG/1MG/5MCG/1%/ML INJECTABLE 10 MLS; TRIMIX/LIDOCAINE 17.65MG/0.59MG/5.9MCG/2% INJECTABLE 10 ML (4 DIFFERENT PRODUCTS)

D-1630-2012

May 21, 2012

Class II

Product summary

Firm
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Event
Event 62443
Status
Terminated
Classification
Class II
Quantity
10 units
Official record key
drug-enforcement:D-1630-2012

Official wording

Reason: 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.

Code information: Rx #'s: 0389839 0389283 0404785 0390956

Distribution pattern: Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    fungal growth
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility