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.
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).