According to US health regulators, drugmakers Aurobindo Pharma, Glenmark and Zydos are recalling products in the US market due to manufacturing problems.
According to the latest enforcement report of the US Food and Drug Administration (USFDA), Hyderabad-based drugmaker Aurobindo Pharma USA Inc. is recalling more than one lakh bottles of multiple strengths of cinacalcet tablets.
The New Jersey-based firm said the US health regulator is recalling the product due to “a GMP deviation: the presence of an N-nitroso cinacalcet impurity above the FDA recommended interim limit”.
The company started the recall on Class 2 on November 7 this year. Cinacalcet tablets are used to treat hyperparathyroidism.
Similarly, the US subsidiary of Glenmark Pharmaceuticals is recalling about 90,000 bottles of diltiazem hydrochloride extended release capsules (multiple strengths) from the US market.
New Jersey-based Glenmark Pharmaceuticals Inc. is recalling an affected lot of diltiazem hydrochloride extended-release capsules due to a “cGMP deviation: the presence of an N-nitroso-desmethyl-diltiazem impurity above the interim limit recommended by the FDA,” the US health regulator said.
Diltiazem hydrochloride extended-release capsules are used to treat high blood pressure. The company initiated a nationwide (US) Class 2 recall on November 1 of this year.
The USFDA further said that Zydus Pharmaceuticals (USA) Inc is recalling 4,404 packs of Esomeprazole Magnesium for Delayed-Release Oral Suspension (40 mg) due to a labeling error.
This medicine is used to treat certain stomach and esophagus problems. The company began a nationwide recall of the affected packs on November 14.
According to the USFDA, a Class II recall is initiated in a situation where use or exposure to the infringing product may cause temporary or medically reversible adverse health consequences or where the likelihood of serious adverse health consequences is remote.
India is the largest supplier of generic drugs accounting for nearly 20 percent of the global supply and producing 60,000 different generic brands across 60 therapeutic categories.
Products manufactured in the country are shipped to more than 200 countries, with Japan, Australia, Western Europe and the US being the main destinations.