<p>New Delhi: Drug makers Aurobindo Pharma, Glenmark and Zydus are recalling products in the US market due to manufacturing issues, according to the US health regulator.</p>.<p>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 1 lakh bottles of Cinacalcet tablets in multiple strengths.</p>.<p>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.</p>.Ballari maternal deaths: Drugs Controller fired, pharma company to face prosecution.<p>The company initiated the Class II recall on November 7 this year. Cinacalcet tablets are used to treat hyperparathyroidism.</p>.<p>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.</p>.<p>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.</p>.<p>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.</p>.<p>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.</p>.FDA approves the first new schizophrenia drug in decades.<p>The medication is used to treat certain stomach and esophagus problems. The company initiated the nationwide recall of the affected packs on November 14.</p>.<p>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.</p>.<p>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.</p>.<p>The products manufactured in the country are shipped to over 200 countries, with Japan, Australia, West Europe, and the US as main destinations.</p>
<p>New Delhi: Drug makers Aurobindo Pharma, Glenmark and Zydus are recalling products in the US market due to manufacturing issues, according to the US health regulator.</p>.<p>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 1 lakh bottles of Cinacalcet tablets in multiple strengths.</p>.<p>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.</p>.Ballari maternal deaths: Drugs Controller fired, pharma company to face prosecution.<p>The company initiated the Class II recall on November 7 this year. Cinacalcet tablets are used to treat hyperparathyroidism.</p>.<p>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.</p>.<p>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.</p>.<p>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.</p>.<p>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.</p>.FDA approves the first new schizophrenia drug in decades.<p>The medication is used to treat certain stomach and esophagus problems. The company initiated the nationwide recall of the affected packs on November 14.</p>.<p>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.</p>.<p>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.</p>.<p>The products manufactured in the country are shipped to over 200 countries, with Japan, Australia, West Europe, and the US as main destinations.</p>