Hyderabad: Sun Pharmaceutical Industries has started recalling two batches of Riomet (metformin hydrochloride) Oral Solution voluntarily from the US market due to microbial contamination.
According to a notification put up by the US Food and Drug Administration on its website, the recall was initiated by the firm under ‘Class-II’ classification. The notification did not mention the quantity that is being recalled.
“The Riomet (Metformin Hydrochloride Oral Solution) has been found to be contaminated (with 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 Pharma informed the FDA in a letter.
Riomet (metformin oral solution) is an oral diabetes medicine that helps control blood sugar level.
According to the USA health regulator, Class II recall is 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.
The drug was manufactured for Ranbaxy Laboratories Inc Jacksonville in the USA by a contract manufacturer and distributed by Sun Pharmaceutical Industries’ subsidiary in Cranbury, New Jersey.