Several major pharmaceutical companies, including Sun Pharma, Cipla, Zydus, and Graviti Pharmaceuticals, are recalling various products in the US due to manufacturing issues, according to recent US FDA enforcement reports. The recalls are primarily related to problems with impurities, quality control, and production processes.
Sun Pharma is recalling over 24,000 bottles of Fluocinolone Acetonide topical solution and Clindamycin Phosphate topical solution due to out-of-specification results for impurities and assay. Cipla is recalling more than 15,000 syringes of Lanreotide Injection, used to treat a rare hormonal condition, due to production issues at its Greek manufacturing partner, Pharmathen. The production of Lanreotide has been temporarily paused to address quality concerns, resulting in limited supply.
Additionally, Cipla is recalling over 92,000 tubes of Diclofenac Sodium Topical Gel due to failed pH specifications. Graviti Pharmaceuticals is recalling over 4,000 bottles of Furosemide Tablets due to the presence of a foreign substance. Zydus Pharmaceuticals is recalling over 22,000 bottles of Icosapent Ethyl capsules due to oxidation caused by leakage, which may lead to inconsistent therapeutic effects and increased gastrointestinal side effects.
These recalls highlight the importance of quality control and manufacturing standards in the pharmaceutical industry. The FDA’s enforcement actions aim to ensure that products meet strict safety and efficacy standards to protect public health. The recalls may result in temporary shortages of these products, and patients are advised to consult their healthcare providers for alternative treatments.
The recalls also underscore the need for pharmaceutical companies to maintain robust quality control systems and adhere to good manufacturing practices (GMPs) to prevent such issues. The companies involved are taking corrective actions to address the problems and prevent future occurrences. The FDA will continue to monitor the situation and take further action if necessary to ensure the safety and efficacy of pharmaceutical products in the US market.