GLYCERIN 99.5% OPHTHALMIC 10 ML, 5 ML, 7.5 ML; GLYCERIN 100% OPHTHALMIC 15 ML (4 DIFFERENT PRODUCTS)

Recall Number: D-1530-2012

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

Classification: Class II

Status: Terminated

Report Date: 20120822

Initiation Date: 20120525

Termination Date: 20140813

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.

GLYCERIN 99.5% OPHTHALMIC 10 ML, 5 ML, 7.5 ML; GLYCERIN 100% OPHTHALMIC 15 ML (4 DIFFERENT PRODUCTS)