Domestic drugmakers Glenmark, Granules India, Sun Pharma, Zydus and Unichem are recalling products in the US market for various manufacturing issues, according to the US Food and Drug Administration (USFDA).
The drugmakers are voluntarily recalling affected lots in the American market, the US health regulator said in its latest Enforcement Report.
A US-based subsidiary of the Mumbai-based Glenmark Pharmaceuticals is recalling 13,824 Azelaic Acid Gel tubes produced at the company’s Goa plant due to “CGMP deviations” following market complaints received for gritty texture, USFDA said.
New Jersey-based Glenmark Pharmaceuticals Inc, USA, initiated the Class II nationwide recall on September 17.
As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.
Hyderabad-based Granules India is recalling over 49,000​Domestic drugmakers Glenmark, Granules India, Sun Pharma, Zydus and Unichem are recalling products in the US market for various manufacturing issues, according to the US Food and Drug Administration (USFDA).
The drugmakers are voluntarily recalling affected lots in the American market, the US health regulator said in its latest Enforcement Report.
A US-based subsidiary of the Mumbai-based Glenmark Pharmaceuticals is recalling 13,824 Azelaic Acid Gel tubes produced at the company’s Goa plant due to “CGMP deviations” following market complaints received for gritty texture, USFDA said.
New Jersey-based Glenmark Pharmaceuticals Inc, USA, initiated the Class II nationwide recall on September 17.
As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.
Hyderabad-based Granules India is recalling over 49,000 ​Latest News [ SOBAN NEWS: International and National ]
