METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/B12 (C) 0.8/1.6/1.6/0.0001/0.03% INJE 10 ML 200 ML 30 ML 50 ML; METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/B12 (M) 0.8/1.6/1.6/0.0001/0.03% INJE 10 ML 150 ML 180 ML 30 ML 360 ML 4 ML 5 ML; METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/VIT B-12 0.8/1.6/1.6/0.0001/0.03% IN 30 ML; METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROMIUM CHLORIDE 0.8/1.6/1.6/0.0001/0.03% 100 ML 30 ML 80 ML; METHIONINE/INOSITOL/CHOLINE CHLORIDE/VIT B12 0.8%/1.6%/1.6%/1200MCG/ML INJECTABL 30 ML; METHIONINE/INOSITOL/CHOLINE CL/B6/B12/CHROM/ (C) 25/50/50/100/1MG/4MCG 5 ML; METHIONINE/INOSITOL/CHOLINE/CHROMIUM W/O B-12 0.8/1.6/1.6/0.0001% INJECTABLE 30 ML (18 DIFFERENT PRODUCTS)

Recall Number: D-1572-2012

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.

METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/B12 (C) 0.8/1.6/1.6/0.0001/0.03% INJE 10 ML 200 ML 30 ML 50 ML; METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/B12 (M) 0.8/1.6/1.6/0.0001/0.03% INJE 10 ML 150 ML 180 ML 30 ML 360 ML 4 ML 5 ML; METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/VIT B-12 0.8/1.6/1.6/0.0001/0.03% IN 30 ML; METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROMIUM CHLORIDE 0.8/1.6/1.6/0.0001/0.03% 100 ML 30 ML 80 ML; METHIONINE/INOSITOL/CHOLINE CHLORIDE/VIT B12 0.8%/1.6%/1.6%/1200MCG/ML INJECTABL 30 ML; METHIONINE/INOSITOL/CHOLINE CL/B6/B12/CHROM/ (C) 25/50/50/100/1MG/4MCG 5 ML; METHIONINE/INOSITOL/CHOLINE/CHROMIUM W/O B-12 0.8/1.6/1.6/0.0001% INJECTABLE 30 ML (18 DIFFERENT PRODUCTS)