Pharmaceutical companies like Sun Pharma and Lupin are recalling their products from the US market due to manufacturing issues, according to the US Food and Drug Administration (USFDA).
Sun Pharmaceutical Industries, based in Mumbai, is recalling 96,192 bottles of Liothyronine Sodium Tablets used to treat an underactive thyroid. The recall, initiated by Sun Pharmaceutical Industries Inc, the company’s Princeton-based unit, involves a lot produced at the Dadra facility. The recall is attributed to “failed impurities/degradation specifications,” and it began as a voluntary nationwide Class II recall on December 4.
Lupin, headquartered in Mumbai, is also conducting a recall of an unspecified quantity of penicillamine tablets in the US. These tablets are used for treating rheumatoid arthritis and Wilson’s disease. The recall, initiated by Lupin Pharmaceuticals Inc, the Baltimore-based unit, involves a lot produced at the Nagpur facility. The recall is due to “failed dissolution specifications,” and it started as a Class II nationwide (US) voluntary recall on November 22.
A Class II recall is enacted when the use of a product may cause temporary or medically reversible adverse health consequences, or the likelihood of serious adverse health consequences is remote, according to the USFDA. The Indian pharmaceutical industry ranks third globally by volume, with the US representing the largest market for pharmaceutical products.
