Sun’s Caraco Issues Voluntary Recall of Metformin

Caraco Pharmaceutical Laboratories, Ltd. issued a Class II recall of the diabetes drug metformin HCl extended-release  (ER) tablets, USP, 500 mg, prescription only, 500-count bottles due to the presence of foreign tablet based on a  customer complaint of some tablets of the epilepsy drug gabapentin was ound in a bottle of metformin HCl ER, according to FDA's March 5th enforcement report. A  Class II recall is where a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote, according to FDA. Caraco is a subsidiary of Sun Pharma USA, which is part of India's Sun Pharmaceutical Inc. Ltd. The voluntary recall is ongoing and was initiated on January 28, 2014 and applies to 2528 bottles .

Source: FDA

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