Indian drug firms like Marksans Pharma, Aurobindo Pharma, Zydus and Jubilant are recalling products in the US market, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Marksans Pharma is recalling diabetes drug, Zydus Pharmaceuticals (USA) is recalling drug which is used to reduce stomach acid. Similarly, Aurobindo Pharma (USA) is recalling pain relieving drug, while Jubilant Cadista is recalling a medication used to treat schizophrenia.
As per the USFDA, Marksans Pharma is recalling close to six lakh bottles of diabetes drug Metformin Hydrochloride extended-release tablets in strengths of 500 mg and 750 mg in the US market. The medication lot has been manufactured at the company’s Goa-based manufacturing facility.
As per the USFDA, the company is recalling the product due to deviation from the current good manufacturing practices (CGMP). ”FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level,” it noted.
NDMA has been defined as a probable human carcinogen. Metformin Hydrochloride extended-release tablet is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type-2 diabetes mellitus.
Various companies across the globe have announced similar recalls for the product after the USFDA pointed out presence of NDMA above permissible limits. FDA’s testing has shown elevated levels of NDMA in some extended release (ER) metformin formulation, but not in the immediate release (IR) formulation or in the active pharmaceutical ingredient.
NDMA is classified as a probable human carcinogen based on results from laboratory tests. It is a known environmental contaminant and found in water and food, including meats, dairy products and vegetables. Further, the USFDA said Zydus Pharmaceuticals (USA) is recalling 14,748 cartons of Lansoprazole delayed-release orally disintegrating tablets due to failed dissolution specification. The product has been manufactured by Ahmedabad-based Cadila Healthcare.
The USFDA has classified the initiatives taken by Marksans and Zydus as class II recalls. As per the USFDA, a class II recall is initiated in 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.
Further, the US health regulator said Aurobindo Pharma USA is recalling 7,440 bottles of Ibuprofen oral suspension drug for labelling error. Besides, Jubilant Cadista Pharmaceuticals, Inc is recalling 23,616 blister packs of Olanzapine orally disintegrating tablets for being ”subpotent”, the USFDA noted.
The recalled lot has been produced by Roorkee-based (Uttarakhand) Jubilant Generics. The US health regulator classified both the recalls as class III.
As per the USFDA, a class III recall is initiated in a ”situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences”.