New Delhi: Dr. Reddy’s Laboratories Ltd. and Sun Pharmaceutical Industries Ltd. are recalling products in the United States because of manufacturing issues, according to the recent Enforcement Report from the US Food and Drug Administration.
The report states that Dr Reddy’s Laboratories is issuing a recall for medications used to treat insomnia and gout in the US market.
Dr Reddy’s Laboratories, Inc., based in New Jersey and part of the Hyderabad-based pharmaceutical giant, is recalling 13,752 bottles of Eszopiclone tablets, according to the USFDA.
The lot in question was manufactured at Dr. Reddy’s Bachupally facility located in Telangana.
As per the USFDA, the drug firm is recalling the affected lot due to ‘Failed Impurities/Degradation Specifications’.
The company issued the Class III nationwide recall on June 4 this year.
The USFDA said a US-based unit of Sun Pharma is recalling 2,088 vials of Decitabine for Injection (50mg per vial) due to ‘CGMP Deviations’.
The affected lot of the chemotherapy medication was produced at Sun Pharma’s Gujarat-based manufacturing plant.
New Jersey-based Sun Pharmaceutical Industries Inc. initiated the nationwide Class II recall on July 2 this year.
As per the USFDA, a Class II recall is initiated in a situation in which the 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.
