Drug major Wockhardt is recalling over 8,000 bottles of anti-hypertension drug Metoprolol Succinate extended-release tablets in the US market following failure of a dissolution test.
According to US Food and Drug Administration (FDA), Wockhardt USA Inc, a subsidiary of the Mumbai-based firm, was voluntarily recalling 8,712 bottles of the drug in the American market.
The recall is due to the "failure of dissolution test observed at three month time point", the US health regulator said.
The nationwide recall was initiated on April 10. 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".
Comments from Wockhardt could not immediately be obtained.
Shares in Wockhardt, on Thursday, ended at Rs 573.55 apiece on the BSE, up 0.16 per cent from the previous close.