PHENYLEPHRINE/TROPICAMIDE (P.F.) SOLUTION 2.5%/1% OPHTHALMIC 5 ML (1 PRODUCT)

Recall Number: D-1600-2012

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

Classification: Class II

Status: Terminated

Report Date: 20120822

Initiation Date: 20120521

Termination Date: 20140815

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.

PHENYLEPHRINE/TROPICAMIDE (P.F.) SOLUTION 2.5%/1% OPHTHALMIC 5 ML (1 PRODUCT)