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Glenmark, Sun Pharma and two others recall products in US

As per the latest Enforcement Report by the US Food and Drug Administration (FDA), Glenmark is recalling over 6.5 lakh tubes of a generic skin treatment ointment due to manufacturing issues

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Glenmark, Sun Pharma, Dr Reddy’s and Jubilant Cadista are recalling multiple products in the US market, due to various issues.

As per the latest Enforcement Report by the US Food and Drug Administration (FDA), Glenmark is recalling over 6.5 lakh tubes of a generic skin treatment ointment due to manufacturing issues.

New Jersey-based Glenmark Pharmaceuticals Inc, a subsidiary of the company, is recalling affected lot of Tacrolimus Ointment, which is used to treat eczema, due to “Defective Container,” it added. The company initiated the nationwide class-III recall on 11th July this year.

The affected lot has been manufactured in India and distributed in the US by Glenmark Pharmaceuticals Inc, the report stated. As per the FDA, a class-III recall is initiated in a “situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”

As per the FDA, Sun Pharma is recalling 9,552 bottles of epilepsy treatment drug Divalproex Sodium delayed-release tablets due to “Failed Dissolution Specifications.” The affected lot has been produced at the company’s Halol plant in Gujarat and distributed in the US by Cranbury-based Sun Pharmaceutical Industries, Inc.

The New Jersey-based firm initiated the class-11 nationwide recall on 13th July. Besides, Jubilant Cadista Pharmac is recalling 38,160 bottles of Irbesartan Tablets (150 and 75 mg), used to treat high blood pressure.

The affected lot has been produced at Jubilant Generics’ Roorkee plant, FDA said. The Salisbury-based drug firm initiated the class-II recall on 18th July.

Edits by EP News Bureau

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