Last Updated on October 10, 2024 by The Health Master
New Delhi: Drug makers Glenmark, Strides Pharma, and Cipla are recalling products in the US, the world’s largest market for medicines, due to manufacturing issues.
Glenmark
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 drugs due to packaging issues.
The USFDA noted in its report that the company, a subsidiary of a 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 of this year.
Strides Pharma
On 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, and 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 the “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.
Cipla
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.
The USFDA stated that New Jersey-based Cipla USA, Inc., a unit of a Mumbai-based drug maker, is recalling the lot due to a “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 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.
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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