Glenmark, Biocon units recall products in the US: USFDA
Glenmark Pharmaceuticals Inc is recalling chlorpromazine hydrochloride tablets in the US, while Biocon Pharma is recalling medicines to treat high cholesterol
New Delhi, Apr 9 (PTI) Drug firms Glenmark and Biocon are recalling products in the US for manufacturing issues, according to the US health regulator.
In its latest Enforcement Report, the US Food and Drug Administration (USFDA) stated that a US-based unit of the Mumbai-based drug firm is recalling a medication to treat various ailments like schizophrenia and anxiety.
New Jersey-based Glenmark Pharmaceuticals Inc is recalling 8,160 bottles of chlorpromazine hydrochloride tablets in the US for "CGMP deviations", USFDA stated.
"Results of the finished product is above the agency's current recommended limit of a Nitrosamine, N-Nitroso-Desmethyl Chlorpromazine impurity," it added.
The company initiated the Class II nationwide (US) recall on March 11 this year.
USFDA stated that US-based Biocon Pharma Inc is recalling 2,184 bottles of a medication to treat high cholesterol.
The company is recalling the affected lot due to "failed dissolution specifications", the US health regulator said.
The company initiated the Class II recall on March 17, 2025.
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.
Shares of Glenmark ended 4.35 per cent down to Rs 1,376.35 apiece on the BSE on Wednesday.
Biocon shares, on the other hand, ended 5.33 per cent down at Rs 305.20 a piece on the BSE. PTI