Sun Pharmaceutical Industries Ltd. unit Sun Pharmaceutical Industries Inc. is voluntarily recalling two lots of type 2 diabetes drug Riomet due to microbial contamination.
The contamination was found during sample preparation for an antimicrobial preservative effectiveness testing being performed as part of the 12-month stability study interval.
Sun Pharmaceutical classified the recall as a retail level class 2 recall. According to the U.S. Food and Drug Administration, class 2 recalls occur when the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The product was manufactured for the company by a contract manufacturer.
