Cipla, Glenmark and 1 other recall products in US over manufacturing issues
As per the USFDA, homegrown drug major Cipla is recalling 7,992 bottles of Difluprednate Ophthalmic Emulsion, used to treat swelling and pain after eye surgery, in the US market.
New Delhi: Drug makers Glenmark, Strides Pharma and Cipla are recalling products in the US due to manufacturing issues.
As per the latest Enforcement Report issued by the US Food and Drug Administration (USFDA), New Jersey-based Glenmark Pharmaceuticals Inc is recalling over 72,000 units of blood pressure lowering drug due to packaging issues.
The USFDA 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 USFDA stated that Glenmark initiated the Class II nationwide (US) recall on June 29 this year.
In a separate note, the US 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 US by New Jersey-based Strides Pharma Inc. As per the USFDA, 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 USFDA, homegrown drug major Cipla is recalling 7,992 bottles of Difluprednate Ophthalmic Emulsion, used to treat swelling and pain after eye surgery, in the US market.
New Jersey-based Cipla USA, Inc, a unit of Mumbai-based drug maker, is recalling the lot due to "lack of assurance of sterility", the USFDA stated.
There were complaints regarding "defective container closure," it added. The affected lot was manufactured in India and marketed in the US by Cipla USA, Inc.
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.
The US is by far the largest market for pharmaceutical products in the world. In the last financial year, India's pharma exports stood at around USD 24.62 billion with the US, UK, South Africa, Russia, and Nigeria emerging as the top five destinations.
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