The FDA has asked Caraco Pharmaceutical Laboratories to withdrawal batches of its generic Metformin Hydrochloride tablets used for treating diabetes, citing efficacy and quality issues.
The agency said the withdrawal was necessitated by undersized and oversized tablets, which could result in patients not receiving the expected dose. The FDA said the recall was valid nationwide and 22,156 bottles of the drug were in circulation in the U.S.
Metformin Hydrochloride, the generic version of Bristol Myers Squibb’s Glucophage, and was launched by the Detroit-based Caraco in the U.S. in February 2002. Caraco is a subsidiary of Mumbai, India-based Sun Pharmaceuticals Industries.
Caraco had sales of $117 million in fiscal year 2007, and markets over 40 products in the U.S.