Pharma major Dr. Reddy’s Laboratories has voluntarily started recalling some of its drugs used to treat seizure and hypertension from the US market.
According to the enforcement report of the USFDA, for the week ended June 24, the company last month initiated recall of Divalproex Sodium extended-release tablet as it failed dissolution tests. Amlodipine besylate and Atorvastatin calcium tablets were also recalled by the company as they have become subpotent drug (closer to their expiry date), USFDA said. The drugs were manufactured at the Bachupally facility of the company in Hyderabad. It was recalling Divalproex Sodium Extended-Release Tablets, USP, 250 mg (100 count and 500 count bottles) and 500 mg (100 count bottles). The drug, used to treat certain types of seizures, was recalled for “failed dissolution specifications; exceeded specification at the 9-hour time point”. As regards the other two drugs, used to treat hypertension or chest pain, some were being recalled.