Prominent pharmaceutical companies, Sun Pharma and Lupin, have initiated product recalls in the US market due to manufacturing issues, according to the US Food and Drug Administration (USFDA).
Sun Pharmaceutical Industries, headquartered in Mumbai, is recalling 96,192 bottles of Liothyronine Sodium Tablets in the US, used for treating underactive thyroid conditions.
The recall is attributed to “failed impurities/degradation specifications,” as per the USFDA. Sun Pharma’s unit, Sun Pharmaceutical Industries Inc, located in Princeton, is conducting the voluntary nationwide Class II recall, commencing on December 4, 2023. The affected lot was produced at the Dadra-based facility.
Simultaneously, Lupin, based in Mumbai, is recalling an unspecified quantity of penicillamine tablets in the US, used for treating rheumatoid arthritis and Wilson’s disease. Lupin Pharmaceuticals Inc, based in Baltimore, is the unit carrying out the voluntary recall, which started on November 22, 2023. The recall is attributed to “failed dissolution specifications,” according to the USFDA.
In FDA terms, a Class II recall is initiated when exposure to a violative product may cause temporary or medically reversible adverse health consequences. The Indian pharmaceutical industry ranks as the third-largest globally by volume, with the US being the largest market for pharmaceutical products.
