Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalls MAGNESIUM CHLORIDE, PRESERVATIVE FREE 20% INJECTABLE 100 ML 1000 ML 500 ML 600 ML
Recalled August 22, 2012 · FDA recall D-1568-2012 · Franck's Lab Inc.,
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. · FDA Class II
Units
32 units
Sold at
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
Description
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.
Product
MAGNESIUM CHLORIDE, PRESERVATIVE FREE 20% INJECTABLE 100 ML 1000 ML 500 ML 600 ML 750 ML; MAGNESIUM SULFATE 50% (500MG/ML) INJECTABLE 14 ML 20 ML 4 ML; MAGNESIUM SULFATE IN 5% DEXTROSE 1% (1GM/100ML) INJECTABLE 2400 ML; MAGNESIUM SULFATE IN 5% DEXTROSE 4% (2GM/50ML) INJECTABLE 1200 ML; MAGNESIUM SULFATE, P.F. 50% (500MG/ML) INJECTABLE 180 ML 240 ML 4 ML 6 ML (14 DIFFERENT PRODUCTS)
Manufacturer(s)
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →