Leading drugmakers Sun Pharma and Lupin are recalling products in the U.S. market over manufacturing issues, as per the US Food and Drug Administration.
Mumbai-based Sun Pharmaceutical Industries is recalling 96,192 bottles of Liothyronine Sodium Tablets in the U.S. that are used to treat an underactive thyroid, according to the latest enforcement report issued by the American health regulator.
Princeton-based Sun Pharmaceutical Industries Inc, a unit of the company, is recalling the affected lot that was produced at the drugmaker's Dadra-based facility.
The company is recalling the lot due to "failed impurities/degradation specifications", the USFDA stated.
The company commenced the voluntary nationwide Class II recall on Dec. 4, this year.
U.S. FDA stated that Mumbai-based Lupin is also recalling an unspecified number of penicillamine tablets in the U.S.
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.
As per the U.S. FDA, the company is recalling the affected lot due to "failed dissolution specifications".
The company initiated the Class II nationwide (U.S.) voluntary recall on Nov. 22.
As per the U.S. FDA, 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.
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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