Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalls ASCORBIC ACID (BEET SOURCE) 500MG/ML INJECTABLE 100 ML, 150
Recalled Product
ASCORBIC ACID (BEET SOURCE) 500MG/ML INJECTABLE 100 ML, 150 ML, 200 ML, 250 ML, 300 ML, 400 ML, 500 ML, 60 ML; ASCORBIC ACID (CORN SOURCE) 500MG/ML INJECTABLE 100 ML; ASCORBIC ACID, 50ML SDPF, VIAL** 500MG/ML INJECTABLE 50 ML, 500 ML; ASCORBIC/B1/B2/B3/B5/B6/B12/METHIONINE/INOSITOL/CHOLINE/LIDO INJECTABLE 40 ML, 50 ML, 60 ML (14 DIFFERENT PRODUCTS)
Hazard / Issue
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.
Issued by
FDA
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