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Sun Pharma’s arm recalls diabetes drug in US over microbial contamination

25 Nov 2017 Evaluate

Sun Pharmaceutical Industries’ US- based subsidiary -- Sun Pharmaceutical Industries Inc (SPII) -- is voluntarily recalling two lots of Riomet (Metformin Hydrochloride Oral Solution), to the retail level due to microbial contamination. The product is manufactured for SPII by a contract manufacturer. The Riomet has been found to be contaminated with microbe, Scopulariopsis brevicaulis.

The contamination was discovered during sample preparation for the antimicrobial preservative effectiveness testing (AMPET) being performed as part of the 12 month stability study interval.

Sun Pharmaceutical Industries is the world’s fourth largest specialty generic pharmaceutical company and India’s top pharmaceutical company.

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