Sun Pharma recalls 50,868 bottles of diabetes drug in US

The tablets were produced at drug major's Halol (Gujarat) based manufacturing plant

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Drug Recall FDA
Picture: Pixabay

Last Updated on May 23, 2021 by The Health Master

Drug major Sun Pharma is recalling 50,868 bottles of diabetes drug Metformin HCl extended-release tablets in the US market, according to the US Food and Drug Administration (USFDA).

The US-based arm of the drug firm is recalling the affected lot of 500 mg tablets (in 500 count bottles) due to “presence of foreign substance identified as activated carbon”, as per the latest Enforcement Report issued by the US health regulator.

The tablets were produced at drug major’s Halol (Gujarat) based manufacturing plant and later distributed in the US by Cranbury (NJ) based Sun Pharmaceutical Industries, Inc.


Other recalls:

Lupin, Sun, Jubilant recall generic medicines in US

Sun Pharma, Alembic recall products in the US market

Zydus Cadila, Alembic Pharma recall these 2 drugs in US


The USFDA has classified the voluntary recall undertaken by the drugmaker as class II recall.

As per the USFDA, a class II recall is initiated in a situation in which 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.

Sun Pharmaceutical Industries has initiated the nationwide recall on May 4 this year. Shares of the drug major ended 0.52 percent up at Rs 690.35 apiece on the BSE on Friday.


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