Sun Pharma Recalls two Batches of Diabetes Drug – Latest News
India’s largest drugmaker Sun Pharmaceutical Industries is now summoning back two batches of its oral diabetes medicine Riomet in the U.S. due to a microbial contamination.
This product, which is indicated to treat type 2 diabetes mellitus in adult and children age 10 and above, is manufactured for Sun by a contract manufacturer. The Riomet lots have been found to be contaminated (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.
Use of Riomet could result in a risk of infection, especially in the immunocompromised patient. The most plausible portal of entry of Scopulariopsis brevicaulis is the respiratory tract, where it may cause pneumonia, sinusitis and disseminated infections.
The recalled Riomet lots bear NDC Code 10631-206-01 Lot A160031A and NDC 10631-206-02 with both having expiry dates of 01/2018. The contaminated product was distributed across the US to wholesale customers.
The company says that as of now it hasn’t got any reports of adverse incidents associated to the recall of Riomet.
Sun Pharmaceutical has warned consumers who have the recalled diabetes medicine
to stop using it and either return it to where they had bought or discard it. It has also advised them to contact their doctor if needed.
