PlainRecalls
FDA Drug Moderate Class II Terminated

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;

Reported: August 22, 2012 Initiated: May 21, 2012 #D-1572-2012

Product Description

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)

Reason for Recall

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.

Details

Units Affected
78 units
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
Location
Ocala, FL

Frequently Asked Questions

What product was recalled? ▼
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). Recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab. Units affected: 78 units.
Why was this product 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 22, 2012. Severity: Moderate. Recall number: D-1572-2012.

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