FDAFDA · Food and drugs·Recall number D-1572-2012
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)
Published August 22, 2012 · Recall initiated: May 21, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Distributor
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
- Lot
- Rx #'s: 0391506 0387832 0379379 0384684 0393073 0401183 0362996 0390985 0391304 0391536 0401641 0405794 0381389 0354014 0394430 0376201 0391434 0391655 0399075 0399950 0400595 0401944 0406909 0408906 0408911 0409594 0409904 0394430 0406648 0372200 0387977 0389172 0390806 0392300 0392584 0394307 0394757 0398054 0398203 0399720 0400786 0402244 0402746 0406118 0406497 0409911 0410108 0394860 0363347 0406812 0394712 0374379 0395812 0402219 0371817 0380501 0403485
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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