Mumbai-based generic drug maker Wockhardt Ltd on Tuesday said that it will recall some remaining drugs manufactured at its two plants in India—Chikalthana and Waluj in Aurangabad, Maharashtra—from the US market ahead of a potential US Food and Drug Administration (FDA) import alert.

The US drug regulator had banned drug imports from Wockhardt’s two plants in 2013 citing flawed manufacturing processes.

The drug maker on Tuesday said that during the last USFDA CGMP (current good manufacturing practices) inspection of the facilities last year, some observations were made pertaining to batches of some products manufactured prior to the ban.

“As a measure of preparedness and as an abundant precaution, the company has now decided to recall, as a part of remedial measure, all the remaining batches in the US market that were manufactured prior to the USFDA (Food and Drug Administration) import alerts, even though there is no evidence of risk to patient safety from the products currently available in the US market,” Wockhardt said in a filing to the BSE on Tuesday.

“Whereas the company continues to supply some of the products in the US market manufactured in the same facilities, several batches of other products, manufactured prior to the import alerts, may still be in the US market,” Wockhardt said. Now, it has decided to recall those drugs.

The FDA has in recent months raised concerns about manufacturing practices at the India-based plants of several firms, including Lupin Ltd and Sun Pharmaceutical Industries Ltd.

Source:livemint.com