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Indian Pharmaceutical Company Recalls Anti-seizure and Hypertension Drugs from US Market

by Shirley Johanna on Jun 30 2015 11:39 PM

Hyderabad-based Dr Reddy’s Laboratories recalled the drugs as the tablets failed dissolution test and some are close to expiry date.

Indian Pharmaceutical Company Recalls Anti-seizure and Hypertension Drugs from US Market
Hyderabad-based Dr Reddy’s Laboratories has recalled some drugs from the US market that are used to treat hypertension and seizure.
The firm started recalling the tablets because Divalproex Sodium extended-release tablets has failed dissolution tests and Amlodipine Besylate and Atorvastatin Calcium tablets are close to expiry time.

According to USFDA, the firm has recalled 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 epilepsy is recalled under the “class-II” classification.

Amlodipine Besylate and Atorvastatin Calcium tablets are used to treat high blood pressure (hypertension) or chest pain (angina) are recalled under “class III” classification.

Source-Medindia


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