EDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML; EDTA CALCIUM DISODIUM (PRESERVATIVE FREE) 150MG/ML INJECTABLE 100 ML, 2400 ML, 500 ML; EDTA CALCIUM DISODIUM SOLUTION 2% OPHTHALMIC 5 ML; EDTA DISODIUM (P.F.) 150MG/ML INJECTABLE 1000 ML, 1200 ML, 1500 ML, 400 ML, 500 ML, 900 ML; EDTA DISODIUM (PRESERVATIVE FREE) 150MG/ML INJECTABLE 1000 ML, 2000 ML, 8000 ML; EDTA DISODIUM (PRESERVATIVE FREE) 3%/ML INJECTABLE 12 ML; EDTA DISODIUM IN NATURAL TEARS 1.5% OPHTHALMIC 5 ML; EDTA DISODIUM IN NATURAL TEARS 3% OPHTHALMIC 15 ML, 30 ML (18 DIFFERENT PRODUCTS)

Recall Number: D-1512-2012

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.

EDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML; EDTA CALCIUM DISODIUM (PRESERVATIVE FREE) 150MG/ML INJECTABLE 100 ML, 2400 ML, 500 ML; EDTA CALCIUM DISODIUM SOLUTION 2% OPHTHALMIC 5 ML; EDTA DISODIUM (P.F.) 150MG/ML INJECTABLE 1000 ML, 1200 ML, 1500 ML, 400 ML, 500 ML, 900 ML; EDTA DISODIUM (PRESERVATIVE FREE) 150MG/ML INJECTABLE 1000 ML, 2000 ML, 8000 ML; EDTA DISODIUM (PRESERVATIVE FREE) 3%/ML INJECTABLE 12 ML; EDTA DISODIUM IN NATURAL TEARS 1.5% OPHTHALMIC 5 ML; EDTA DISODIUM IN NATURAL TEARS 3% OPHTHALMIC 15 ML, 30 ML (18 DIFFERENT PRODUCTS)