Dr Reddy's, Sun Pharma Recall Drugs in US: USFDA

New Delhi, Jul 4 (PTI) Dr Reddy's Laboratories and Sun Pharma are recalling products in the US due to manufacturing issues, as per the latest Enforcement Report by the US Food and Drug Administration (USFDA).

According to the report, Dr Reddy's Laboratories is recalling drugs to treat insomnia and gout in the American market.

New Jersey-based Dr Reddy's Laboratories, Inc., a unit of Hyderabad-based drug major, is recalling 13,752 bottles of Eszopiclone tablets, the USFDA stated.

The affected lot has been produced at Dr Reddy's Bachupally plant 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.

As per the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences".

Dr Reddy's Laboratories, Inc. is also recalling 20,520 units of Allopurinol tablets in the US market due to the "presence of foreign substance".

The company initiated the Class II nationwide (US) recall on June 7, 2024, the US health regulator said.

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.