Indian drugmaker Wockhardt Ltd is facing more trouble as it is recalling over one lakh bottles of high blood pressure drug from the US after it failed the dissolution test, the US Food and Drug Administrator posted on its website earlier.
Dissolution tests are conducted to check the time taken for the active ingredient in a drug to release in the body. It also helps determine the performance of the drug.
According to US FDA website, the recall of the drug – metoprolol succinate started in April this year. This drug is a generic version of UK-based AstraZeneca Plc’s branded drug Toprol.
While companies recalling drugs is not uncommon, it’s yet another setback for Mumbai-based pharma player which has earlier run into problems with US drug regulator. Earlier, two plants of Wockhardt were banned by US FDA citing violations of manufacturing standards which it believed compromised on quality of the drug. 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.
These drugs, which are a combination for pain treatment, were banned over concern of safety and efficacy. Last month the regulator revoked its ban.
(Edited by Joby Puthuparampil Johnson)