- The recall is subject to identification of n-nitrosodimethylamine (NDMA) levels in excess of the acceptable limit
- The FDA has classified the ongoing voluntary nationwide recall in the United States as class-II recall
Viona Pharmaceuticals Inc., a wholly-owned subsidiary of Cadila Healthcare, has recalled over 21,000 bottles of metformin hydrochloride extended-release tablets made by Cadila. For the record, metformin hydrochloride extended-release tablets are used to enhance glycemic control in people with type 2 diabetes mellitus. It is used with a proper diet and exercise program and possibly with other medications to control high blood sugar.
As per the recent report by the US Food and Drug Administration, Viona Pharmaceuticals issued a recall for 21,240 bottles of metformin hydrochloride extended-release tablets, USP 750 mg, due to "CGMP Discrepancies: FDA analysis identified n-nitrosodimethylamine (NDMA) levels in abundance of the appropriate daily intake limit.
The ongoing voluntary nationwide recall in the United States is a class-II recall, according to the agency. Apparently, a class-II recall is undertaken when using, or exposure to a violative product may produce momentary or medically treatable adverse health effects or when the risk of severe adverse health effects is remote.
Based on the results of laboratory examinations, NDMA is categorized as a potential human carcinogen. It is a known environmental hazard found in water and foods like meat, dairy, and vegetables.
Alike Viona, Indian drug major, Dr Reddy's Laboratories also recalled 2,980 bottles of Atorvastatin Calcium tablets in the US recently due to quality issues. As per the US FDA report, the company recalled the drug lots of 10 mg strength due to failed impurities degradation specifications.
About Viona –
Viona Pharmaceuticals is a generic pharmaceutical company established in May 2018. The company has introduced several products in 2019 and has many generic medicinal products in development that it plans to launch in the market shortly.
Source Credit - https://www.business-standard.com/article/companies/cadila-healthcare-arm-recalls-21-240-bottles-of-diabetes-drug-in-us-121070400256_1.html