Sun Pharma, Lupin recall drugs in US over manufacturing issues: USFDA

  • Lupin is also recalling an unspecified number of penicillamine tablets in the US due to failed dissolution specifications.
  • Sun Pharma is recalling 96,192 bottles of Liothyronine Sodium Tablets in the US due to failed impurities/degradation specifications.

Livemint
First Published17 Dec 2023, 12:34 PM IST
Representative image of medicines
Representative image of medicines(HT_PRINT)

Leading drugmakers Sun Pharma and Lupin have recalled their products in the US market over manufacturing issues, as per the US Food and Drug Administration (USFDA). 

Mumbai-based Sun Pharmaceutical Industries is recalling 96,192 bottles of Liothyronine Sodium Tablets in the US that are used to treat an underactive thyroid. The company is recalling the lot due to "failed impurities/degradation specifications", the USFDA stated.

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Princeton-based Sun Pharmaceutical Industries Inc, a unit of the company, is recalling the affected lot that was produced at the Dadra-based facility.

Sun Pharma commenced the voluntary nationwide Class II recall on December 4, this year.

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US Food and Drug Administration stated that Mumbai-based Lupin is also recalling an unspecified number of penicillamine tablets in the US.

The medication is used to treat rheumatoid arthritis and Wilson's disease. Baltimore-based Lupin Pharmaceuticals Inc, a unit of the company, is recalling the affected lot that was produced at the drugmaker's Nagpur-based facility.

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As per the USFDA, the company is recalling the affected lot due to "failed dissolution specifications".

The company initiated the Class II nationwide (US) voluntary recall on November 22.

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.

Lupin's Madhya Pradesh facility receives EIR from USFDA

The Indian pharmaceutical industry is the third largest in the world by volume. The US is the world's largest market for pharmaceutical products.

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First Published:17 Dec 2023, 12:34 PM IST
HomeCompaniesNewsSun Pharma, Lupin recall drugs in US over manufacturing issues: USFDA

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