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  1. Glenmark, Biocon to recall meds from the US: USFDA

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Glenmark, Biocon to recall meds from the US: USFDA

Upstox

2 min read | Updated on April 09, 2025, 20:35 IST

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SUMMARY

The US health regulator said that the New Jersey-based Glenmark Pharmaceuticals Inc. was recalling 8,160 bottles of chlorpromazine hydrochloride tablets in the USA due to CGMP deviations.

The report said that the US unit of Glenmark is recalling a medication to treat various ailments like schizophrenia and anxiety. | Image: Shutterstock.

The report said that the US unit of Glenmark is recalling a medication to treat various ailments like schizophrenia and anxiety. | Image: Shutterstock.

Pharmaceutical companies Glenmark and Biocon are recalling medications from the United States due to manufacturing issues, the USFDA said in its latest Enforcement Report.

The report said that the US unit of Glenmark is recalling a medication to treat various ailments like schizophrenia and anxiety.

The US health regulator said that the New Jersey-based Glenmark Pharmaceuticals Inc. was recalling 8,160 bottles of chlorpromazine hydrochloride tablets in the USA due to CGMP deviations.

The affected lot is being recalled due to "failed dissolution specifications", the US health regulator added.

"Results of the finished product are above the agency's current recommended limit of a Nitrosamine, N-Nitroso-Desmethyl Chlorpromazine impurity," the report stated.

The firm 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.

Pharma stock performance

Shares of Glenmark closed in the red at ₹1,376.30 apiece, down 4.48% on the National Stock Exchange (NSE) on Wednesday.

The stock gained 8.24% over the week but lost 10.69% since the beginning of April. The scrip fell 14.47% on a year-to-date basis.

Biocon stock ended 4.96% down at ₹306.30 per share on NSE on April 9.

With PTI inputs
Upstox

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