Recalls / Class II

Class IID-1516-2012

Product

ETHYL ALCOHOL 10% INJECTABLE 30 ML; ETHYL ALCOHOL 100%INJECTABLE 10 ML, 100 ML, 20 ML, 40 ML, 5 ML, 60 ML; ETHYL ALCOHOL 20% INJECTABLE 5 ML; ETHYL ALCOHOL 5% INJECTABLE 180 ML, 30 ML; ETHYL ALCOHOL 95% INJECTABLE 10 ML, 8 ML; ETHYL ALCOHOL OPHTHALMIC 40% INJECTABLE 50 ML (13 DIFFERENT PRODUCTS)

Affected lot / code info

Rx #'s: 0378831 0387603 0391286 0391286 0391286 0396237 0391286 0401965 0392266 0406349 0360543 0406198 0360543 0398555

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 because 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

17 units

Distribution pattern

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

Timeline

Recall initiated

2012-05-25

FDA classified

2012-08-10

Posted by FDA

2012-08-22

Terminated

2014-08-13

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1516-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.