Viona Pharmaceuticals, which Cadila Healthcarewholly owns, is recalling over 21,000 bottles of metformin hydrochloride, a diabetic drug manufactured by Cadila Healthcare on account of 'CGMP Deviations: FDA analysis detected that the n-nitrosodimethylamine (NDMA) levels were in excess than that of the acceptable daily intake limit and daily allowance.
Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. As per USFDA, a class-II recall is initiated in a situation in which use of, or exposure to, the disruptive product may cause temporary or medically reversible adverse health consequences, which increased the probability of serious adverse health consequences in the patients.
NDMA is classified as a probable human carcinogen based on the recently conducted laboratory tests. It is also the most known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Increased levels of this drug might result in adverse effects and can cause severe damage to vital organs. Therefore the Cadila Healthcare has recalled its products to check the amount of NDMA present in its drug.