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Recall Observatory FDA recall evidence

Drug product

METHYLCOBALAMIN/FOLIC ACID - KIT 10MG/0.4MG/ML INJECTABLE 1 KIT METHYLCOBALAMIN/FOLIC ACID 1000MCG/0.4MG/ML INJECTABLE 10 ML METHYLCOBALAMIN/FOLIC ACID 10MG/0.4MG/ML INJECTABLE 10 ML 8 ML 8 MLS

D-1574-2012

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
Unavailable
Official record key
drug-enforcement:D-1574-2012

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: 0369092 0390078 0388491 0404406 0399651 0373092

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