Aurobindo Pharma, Glenmark, and Zydus recall products in US over mfg issues

Drug makers Aurobindo Pharma, Glenmark and Zydus are recalling products in the US market due to manufacturing issues, according to the US health regulator.

As per the latest Enforcement Report of US Food and Drug Administration (USFDA), Aurobindo Pharma USA Inc, a subsidiary of Hyderabad-based drug maker, is recalling over 100,000 bottles of Cinacalcet tablets in multiple strengths.

The New Jersey-based firm is recalling the product due to "GMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit," the US health regulator said.

The company initiated the Class II recall on November 7 this year. Cinacalcet tablets are used to treat hyperparathyroidism.

Similarly, a US-based subsidiary of Glenmark Pharmaceuticals is recalling around 90,000 bottles of Diltiazem Hydrochloride extended-release capsules (multiple strengths) in the US market.

New Jersey-based Glenmark Pharmaceuticals Inc, USA is recalling the affected lot of Diltiazem Hydrochloride extended-release capsules due to "cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit", the US health regulator stated.

Diltiazem Hydrochloride extended-release capsules are used to treat high blood pressure. The company initiated the Class II nationwide (US) recall on November 1 this year.

The USFDA further stated that Zydus Pharmaceuticals (USA) Inc is recalling 4,404 packs of Esomeprazole Magnesium for Delayed-Release Oral Suspension (40 mg) due to a labelling error.

The medication is used to treat certain stomach and esophagus problems. The company initiated the nationwide recall of the affected packs on November 14.

As per the USFDA, a Class II recall is initiated in a situation in which the 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.

India is the largest supplier of generic medicines with around 20 per cent share in the global supply by manufacturing 60,000 different generic brands across 60 therapeutic categories.

The products manufactured in the country are shipped to over 200 countries, with Japan, Australia, West Europe, and the US as main destinations.