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Monday, June 9, 2014

Wockhardt USA Inc has voluntarily recalled 8712 bottles of anti-hypertension drug

Indian drug major Wockhardt's american subsidary has recalled 8,712 bottles of anti-hypertension drug Metoprolol Succinate extended-release tablets in the US market following failure of a dissolution test.

According to United States Food and Drug Administration (USFDA), Wockhardt USA Inc is a subsidiary of Mumbai-based firm is voluntarily recalling 8,712 bottles of the drug in the American market.

The voluntary recall of the drug is due to the "failure of dissolution test observed at three month time point", USFDA said.

The nationwide recall was initiated on April 10 of this year. The 100 mg tablets in 100-count bottles were manufactured by Wockhardt Ltd and distributed in the US market by Wockhardt USA Inc, it added.

The withdrawal was classified as a Class-II recall, which the FDA defines as "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".

Immediate comments from Wockhardt was not available.

The stock plunged more than 10% post last quarter's poor results.

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