 "Wockhardt")
Wockhardt is recalling over five million bottles of various drugs, used for treating ailments like high blood pressure and ulcer, from the US market due to deviations in current good manufacturing practice norms laid down by the American health regulator.
As per the information available on the US Food and Drug Administration’s (USFDA) website, Mumbai-based Wockhardt is recalling the drugs for current good manufacturing practice (CGMP) deviations.
“Firm did not adequately investigate customer complaints,” the US FDA said.
All the drugs being recalled by the company have been manufactured at its Mumbai-based facility and distributed in the US by its subsidiary, Wockhardt USA. Wockhardt did not respond to a query, seeking comment on this latest recall. Earlier this year too, the company was forced to recall its drugs from US market but the latest recall is its biggest so far this year.
The company's manufacturing facilities in Aurangabad came under FDA scanner and in November 2013, the US regulator had imposed an import alert on medicines, manufactured at the plant.
An import alert results in detention without physical examination of drugs from firms that do not meet the good manufacturing practices (GMP), according to FDA.
In May, FDA inspected its facilities at Waluj and Chikalthana plants near Aurangabad and this was followed by an inspection at its plant in Solan in Himachal Pradesh. In April, Wockhardt had informed the Stock Exchange that some observations were made about its products manufactured, prior to the US FDA import alert.
“Several batches of other products, manufactured prior to the import alerts, may still be in the US market. As a measure of preparedness and as an abundant precaution, the company, as a part of remedial measure, has now decided to recall all the remaining batches in the US market that were manufactured prior to the US FDA Import Alerts even though there is no evidence of risk to patient safety from the products currently available in the US market,” the company had said in its April notification.
