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Recall Observatory FDA recall evidence

Drug product

EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJECTABLE 25 ML; EPINEPHRINE HCL SOLUTION 1% OPHTHALMIC 10 ML, 20 ML; EPIINEPHRINE P.F. (SULFITE-FREE) 1:1,000 (1MG/ML) INJECTABLE 1 ML, 2 ML, 20 ML, 25 ML, 3 ML, 30 ML, 4 ML, 5 ML, 50 ML; EPINEPHRINE PF IN BSS, OPHTHALMIC (CONTAINS SULFITES) 1:1000 (1MG/ML) INJECTABLE 15 ML, 16 ML, 30 ML (15 DIFFERENT PRODUCTS)

D-1514-2012

May 25, 2012

Class II

Product summary

Firm
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Event
Event 62416
Status
Terminated
Classification
Class II
Quantity
33 units
Official record key
drug-enforcement:D-1514-2012

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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Code information: Rx #'s: 0397555 0397557 0382534 0400837 0407829 0390562 0390562 0395167 0397757 0396775 0394599 0390562 0396775 0390562 0390562 0396775 0389984 0387701 0389984

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