Dr Reddy’s initiates voluntary recall of drug from US market

The regulator’s website cited “Failed Dissolution Specifications: failure of dissolution test observed at 18 month time point,” as the reason for recall.

Drug maker Dr. Reddy’s Laboratories has initiated voluntary recall of Metoprolol Succinate Extended Release Tablets, USP 25 mg 100-count bottles from the U.S. market following failure of dissolution test, USFDA said.

According to a notification by the FDA, the recall of the 13,560 bottles has been voluntarily initiated by the company through a letter to the regulator last month under ‘Class-II’ classification.

Metoprolol is used alone or in combination with other medications to treat high blood pressure. It also is used to prevent angina (chest pain) and to improve survival after a heart attack.

The regulator’s website cited “Failed Dissolution Specifications: failure of dissolution test observed at 18 month time point,” as the reason for recall.

Tablet Dissolution is a standardised method for measuring the rate of drug release from a dosage form.

Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, (100-count bottle) were manufactured by Dr Reddy’s at one of its Hyderabad manufacturing facilities and distributed by Dr. Reddy’s Laboratories Inc. in the U.S.

According to the U.S. health regulator, Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Shares of Dr. Reddy’s were trading at Rs. 2435.20, up 0.51 per cent on the BSE in the morning trade.