Dr. Reddy’s Laboratories and Aurobindo Pharma separately initiate voluntary recalls of mental disorder drug from US
Hyderabad, Feb 16:Dr. Reddy’s Laboratories and Aurobindo Pharma have separately initiated voluntary recalls of a drug each from the U.S. market. Dr. Reddy’s is recalling Olanzapine tablets USP of 2.5 mg, used in the treatment of schizophrenia and bipolar disorder.
According to a notification posted on the website of the U.S. ‘Food and Drug Administration.’ The recall involves 5,904 bottles (of 30 tablets each) of the product manufactured at the DRL plant in Bachupally, Hyderabad, the regulator said.
Separately, Aurobindo Pharma’s U.S. unit has started recalling its gastroesophageal reflux disease (GERD) treatment Pantoprazole Sodium for injection, 40 mg per vial, from the market. “Discolouration: Some vials were found to contain powder with a yellowish-brownish appearance,” was cited as a reason in the FDA notification on its website.
A total of 29,800 vials is being recalled. The FDA classified the recalls Class III, which according to the regulator, is “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.”