Recalls / Class II

Class IID-1642-2012

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)

Affected lot / code info

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

Why it was recalled

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.

Recalling firm

Firm

Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1210 SW 33rd Avenue, Ocala, Florida 34474-5138

Distribution

Quantity

25 units

Distribution pattern

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

Timeline

Recall initiated

2012-05-21

FDA classified

2012-08-10

Posted by FDA

2012-08-22

Terminated

2014-08-15

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1642-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.