Three major Indian pharmaceutical companies, Sun Pharma, Zydus, and Glenmark, have issued recalls of their products in the United States due to manufacturing issues. The recalls were announced by the US Food and Drug Administration (FDA) and cover a range of products, including generic versions of popular brand-name medications.
Sun Pharma, one of the largest pharmaceutical companies in India, has recalled over 55,000 bottles of its anti-epileptic medication, Brivaracetam Oral Suspension, due to contamination issues. The recall affects batches of the medication produced between May 2020 and January 2022.
Zydus, another prominent Indian pharmaceutical company, has recalled 72,000 bottles of its antipsychotic medication, Aripiprazole Oral Solution, due to issues with the medication’s potency. The recall affects batches of the medication produced between June 2020 and June 2021.
Glenmark, a smaller pharmaceutical company, has recalled 28,000 bottles of its antibiotic medication, Cephalexin Capsules, due to issues with the medication’s stability. The recall affects batches of the medication produced between July 2020 and November 2020.
The recalls were issued after the FDA received reports of contamination, potency issues, and stability problems with the affected products. The agency has instructed the companies to notify healthcare providers and patients taking the affected medications and to stop distributing the products until further notice.
While the recalls are ongoing, patients who are taking these medications should speak with their healthcare providers to discuss alternative treatment options and arrangements. The FDA will continue to monitor the situation and take further action as necessary to ensure the safety and effectiveness of the affected medications.
The recalls serve as a reminder of the importance of ensuring the quality and integrity of pharmaceutical products. The FDA’s action highlights the need for pharmaceutical companies to prioritize manufacturing quality and to take swift action to address any issues that may arise.