Skip to content
Recall Observatory FDA recall evidence

Drug product

VORICONAZOLE OPHTHALMIC 1% (10MG/ML) SOLUTION 15 ML; VORICONAZOLE OPHTHALMIC, (0.5ML, LL SYRINGE), P.F. 0.1% (100MCG/0.1ML) INJECTABL 0.5 ML 1 ML 1.5 ML 2 ML 2.5 ML 5 ML; VORICONAZOLE OPHTHALMIC, P.F. (SINGLE DOSE ONLY) 0.1% (100MCG/0.1ML) INJECTABLE 0.1 ML 1 ML 5 ML (10 DIFFERENT PRODUCTS)

D-1642-2012

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
25 units
Official record key
drug-enforcement:D-1642-2012

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: 0405994 0401042 0405007 0405945 0404546 0404819 0400172 0404384 0400172 0410164 0410169 0410172 0404101 0404101 0404546 0405739 0393586 0393587 0403026 0401576

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