Sun Pharma, Lupin Issue US Drug Recalls Over Manufacturing Concerns: USFDA Reports
Written by Arushi Sharma
Sun Pharma and Lupin respond to USFDA recalls, prompting voluntary product withdrawals. The recalls due to manufacturing issues highlight the significance of quality standards in India's pivotal pharmaceutical exports to the US market.
Leading pharmaceutical companies Sun Pharma and Lupin are in the process of recalling products from the US market due to manufacturing issues, according to disclosures from the US Food and Drug Administration (USFDA). The Mumbai-based Sun Pharmaceutical Industries and Lupin, headquartered in Mumbai as well, are actively addressing these concerns, as indicated by the latest enforcement reports issued by the American health regulator.
Sun Pharmaceutical Industries, based in Mumbai, has initiated the recall of 96,192 bottles of Liothyronine Sodium Tablets in the US, primarily used to treat underactive thyroid conditions. The affected lot, produced at the company's Dadra-based facility and distributed by its unit in Princeton, Sun Pharmaceutical Industries Inc, is being recalled due to "failed impurities/degradation specifications," as stated by the USFDA.
This voluntary nationwide Class II recall commenced on December 4, addressing concerns raised by the USFDA regarding product quality.
Simultaneously, Mumbai-based Lupin is also recalling an unspecified number of penicillamine tablets in the US, utilized in treating rheumatoid arthritis and Wilson's disease. The affected lot, produced at the company's Nagpur-based facility and distributed by its Baltimore-based unit, Lupin Pharmaceuticals Inc, is being recalled due to "failed dissolution specifications," according to the USFDA.
Lupin initiated its voluntary nationwide Class II recall on November 22, adhering to the standards outlined by the USFDA for quality assurance and patient safety.
A Class II recall, according to the USFDA, is initiated in situations where the use of a violative product may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
The pharmaceutical industry in India, ranked as the third-largest globally by volume, plays a significant role in supplying pharmaceutical products worldwide. The US market remains the largest destination for pharmaceutical exports, underlining the importance of stringent adherence to quality standards and regulatory compliance by Indian pharmaceutical firms.