Dr Reddy's recalls over 13,000 bottles of high blood pressure drug in US

Written by PTI | Mumbai | Updated: Jun 19 2014, 17:50pm hrs
Pills-blueQuality-related issues involving Indian pharma companies have hurt the reputation of the industry as a supplier of cheap generic drugs.
Drug maker Dr Reddys Laboratories has initiated voluntary recall of Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottles from US 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 regulators 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 Reddys at one of its Hyderabad manufacturing facilities and distributed by Dr. Reddy's Laboratories Inc. in the US.

According to the US 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. Reddys were trading at Rs 2435.20, up 0.51 per cent on the BSE in the morning trade.