Fearing microbial contamination, Sun Pharmaceutical Industries Ltd. has recalled two batches of its anti-diabetic drug Riomet (Metformin Hydrochloride Oral Solution).
Sun Pharma which is the biggest Indian drug manufacturer by volume and the fourth largest generic drug producer in the world found the oral solution to be contaminated with Scopulariopsis brevicaulis. It is a type of fungus (mold) which can cause infections starting from nail infections to severe life threatening infections like pneumonia , sepsis and widespread disease in the immunocompromised groups like people with cancer, leukemias , diabetes etc. It recalled two lots of 500 mg/5mL vials from retailers.This product is manufactured by SPII, a wholly owned subsidiary of Sun pharmaceutical Industries Ltd. The products with NDC Code 10631-206-01 Lot A160031A, Exp: 01/2018, and NDC 10631-206-02 Lot: A160031B, Exp.: 01/2018 have been recalled.. Consumers who are in possession of these batch numbers and expiry dates have been asked to stop using the medication immediately and hand over the vials to retailers. Consumers have also been advised to contact their physician or healthcare provider if they are experiencing any problems that they suspect may be related to taking or using this drug product.
Metformin Hydrochloride Oral Solution is used for treating Diabetes Mellitus (Type 2) in adults and children above 10 years of age. It is the most widely used first line anti-diabetic medication for patients of diabetes that is usually detected late in the life.
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. This is the latest in a string setbacks Sun Pharma has suffered in recent years.It has already suffered huge financial losses due to issuance of a warning letter by the U S Drug Regulator in December 2015 for violations with Sun’s quality control system after a Food and Drug Administration inspection found lapses at its Halol plant in Gujarat and was subsequently barred from new product launches in US which is the world’s largest drug market. It continues to suffer from quality control issues. The company was again found wanting in quality control processes by the U.S. Food and Drug Administration (FDA) after repeat inspection in Nov -Dec 2016 at the Halol plant.
