FDA forces Wockhardt to withdraw yet another generic drug from US
17 May 2014
Amid mounting troubles for India's generic drugs industry, Wockhardt Ltd on Friday said it is recalling over 100,000 bottles of a high blood pressure drug from the US market after they failed to meet Food & Drug Administration (FDA) standards.
According to an earlier posting on FDA's website, the drug metoprolol succinate failed the 'dissolution test'.
Dissolution tests are conducted to check the time taken for the active ingredient in a drug to release itself in the body. It helps determine the performance of the drug.
According to US FDA website, the recall of metoprolol succinate started in April this year. This drug is a generic version of AstraZeneca Plc's branded drug Toprol.
Earlier, two plants of Wockhardt were banned by the FDA over violations of manufacturing standards. One of those plants manufactured metoprolol succinate.
The drugs that have been recalled, however, were manufactured at Wockhardt's plant in Mumbai.
Apart from problems with US FDA, earlier this year Wockhardt also ran into trouble with drug regulator of Himachal Pradesh.
The regulator had suspended the manufacture, sale or distribution of fixed dose combination of drugs like Dicyclomine Hydrochloride IP 10mg, Tramadol Hydrochloride IP 50mg and Acetaminophen IP 325mg, which are a combination for pain treatment.
However, the state government later lifted the ban.