Mumbai-based Wockhardt Ltd. is recalling more than 100,000 bottles of the hypertension drug metoprolol after it failed a dissolving test.
The U.S. Food and Drug Administration (FDA) announced the voluntary recall in April. Metoprolol is a generic version of the brand-name drug Toprol, made by Astra-Zenica, The Hindu Business Line reports. This action is a Class II recall, the FDA’s intermediate recall level, where there is no immediate danger of death or other serious injury, but those risks are still present.
The recalled drug is Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottles, lot numbers are LN10686, LN10687, LN10688, LN10707, LN10708, with an expiration date of 02/15. A total of 109,744 bottles are being recalled; they were distributed nationwide. The reason for the recall is the drug’s “failure of dissolution test observed at nine-month time point,” according to the notice on the FDA web site. Tablet dissolution is a standardized method for measuring the rate of drug release from a dosage form.
Two of Wockhardt’s Indian facilities were placed on the FDA’s import-alert list last year, one of them a facility that manufactured metoprolol. In the last year, the FDA has increased efforts to monitor the safety and quality of generic drugs, particularly those manufacturer abroad, Bloomberg News reports. Indian companies supply about one quarter of the medicines used in the U.S. In February, FDA Commissioner Dr. Margaret Hamburg made a nine-day visit to India to meet with pharmaceutical makers to discuss production quality and safety issues. The U.S. is its increasing scrutiny of generic drugs made in India.