Sun Pharma, Dr Reddy's Labs recall products in US over manufacturing issues
Dr Reddy's Laboratories and Sun Pharma, two prominent pharmaceutical companies, are conducting recalls of products in the United States following revelations of manufacturing issues. This action stems from the most recent Enforcement Report published by the US Food and Drug Administration (USFDA).
Dr Reddy's Laboratories is recalling medications used to treat insomnia and gout within the American market.
According to the USFDA, New Jersey-based Dr Reddy's Laboratories, Inc., a unit of the Hyderabad-based pharmaceutical giant, has initiated a recall of 13,752 bottles of Eszopiclone tablets, USP 1mg CIV, 30-count bottle, Rx only. The affected lot was manufactured at Dr Reddy's Bachupally plant located in Telangana.
The recall was prompted by concerns over "Failed Impurities/Degradation Specifications," leading to the issuance of a Class III nationwide recall on June 4 of this year.
Class III is initiated in a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences as per USFDA.
In addition to the Eszopiclone tablets, Dr Reddy's Laboratories, Inc. is also recalling 20,520 units of Allopurinol tablets, USP 300mg, 100 Tablets per bottle, Rx only from the US market due to the presence of a foreign substance. This separate recall was initiated as a Class II nationwide recall on June 7, 2024, according to the US health regulator.
Class II is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Meanwhile, Sun Pharma's US-based unit is recalling 2,088 vials of Decitabine for Injection (50mg per vial), due to "CGMP Deviations."
The affected lot of this chemotherapy medication was manufactured at Sun Pharma's plant in Gujarat. New Jersey-based Sun Pharmaceutical Industries Inc. initiated a nationwide Class II recall on July 2 of this year.
Read also: Dr Reddy's Labs, Sun Pharma recall products in American market over manufacturing issues
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