Indian drug company recalls drugs from US market
Poor regulation has led to the recall of several major drugs distributed by Dr. Reddy's Laboratories used to treat hypertension and seizures. The Indian drug manufacturer has recalled these drugs due to their failure in several dissolution tests and their proximity to expiration.
Dr Reddy’s Laboratories has initiated a voluntary recall of some drugs used to treat seizure and hypertension from the U.S. market.
The firm has started recalling Divalproex Sodium extended-release tablets as it has failed dissolution tests, and Amlodipine Besylate and Atorvastatin Calcium tablets since these are close to expiry time.
According to a communication issued by the USFDA, the drug maker has started recalling Divalproex Sodium extended-release tablets, USP, 250 mg of 100 count (7,479 units) and 500 count bottles (2,544) units on the ground of “failed dissolution specifications, exceeded specification at the 9-hour time point”.
The drug, which is used to treat certain types of seizures (epilepsy), is being recalled under the “class-II” classification.
Similarly, the drug major has initiated recall of some lots of Amlodipine Besylate and Atorvastatin Calcium tablets of various strengths in 30-count and 90- count bottles manufactured at DRL’s Bachupally facility in Hyderabad, USFDA said.
The recall of these tablets is being made under “class III” classification.
Amlodipine Besylate and Atorvastatin Calcium tablets are used to treat high blood pressure (hypertension) or chest pain (angina).