Drugmakers Glenmark, Strides Pharma and Cipla are recalling products in the U.S., the world's largest market for medicines, due to manufacturing issues.
As per the latest Enforcement Report issued by the U.S. Food and Drug Administration, New Jersey-based Glenmark Pharmaceuticals Inc. is recalling over 72,000 units of blood pressure lowering drug due to packaging issues.
The U.S. FDA noted in its report that the company, a subsidiary of Mumbai-based drug firm, is recalling the affected lot due to 'blister package issues.' The lot was produced at Glenmark's Pithampur (Madhya Pradesh) based manufacturing facility. The U.S. FDA stated that Glenmark initiated the Class II nationwide (U.S.) recall on June 29 this year.
In a separate note, the U.S. health regulator said a unit of Bengaluru-based Strides Pharma Science is recalling 1,032 bottles of Prednisone tablets, a medication used to treat many conditions including asthma, allergic reactions, arthritis, inflammatory bowel diseases, among others.
The affected lot was produced by Strides Pharma Science and marketed in the U.S. by New Jersey-based Strides Pharma Inc. As per the U.S. FDA, the company is recalling the affected lot due to 'presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone tablets'. The company initiated the Class II voluntary nationwide recall on July 19 this year.
As per the U.S. FDA, homegrown drug major Cipla is recalling 7,992 bottles of Difluprednate Ophthalmic Emulsion, used to treat swelling and pain after eye surgery, in the U.S. market.
New Jersey-based Cipla USA, Inc., a unit of Mumbai-based drugmaker, is recalling the lot due to 'lack of assurance of sterility', the U.S. FDA stated.
There were complaints regarding 'defective container closure', it added. The affected lot was manufactured in India and marketed in the U.S. by Cipla USA, Inc.
As per the U.S. FDA, 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.
The U.S. is by far the largest market for pharmaceutical products in the world. In the last financial year, India's pharma exports stood at around $24.62 billion with the U.S., the U.K., South Africa, Russia, and Nigeria emerging as the top five destinations.
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