Zydus recalls Warfarin tablets in US

Some tablets in the lot were found to be oversized

Zydus Pharmaceuticals USA Inc, a subsidiary of Ahmedabad-based pharma major Cadila Healthcare (popularly known as Zydus Cadila), has voluntarily recalled one lot of Warfarin 2 mg tablets as some tablets of the above lot have been found to be oversized, according to a notice issued by the US drug regulator.

Warfarin is used as a prophylaxis and treatment of venous thrombosis and its extension. Basically, it is a blood thinner that is widely used to prevent blood clots in patients with irregular heartbeats or a history of heart attack.

The company could not be reached for a comment.

The US Food and Drug Control Administration (USFDA) website says, 'four tablets of Warfarin 2mg tablets, Lot MM5767 have been found to be oversized in one product complaint.' The website notice further goes on to say that ingestion of a greater dose of Warfarin could lead to an increased pharmacological effect of Warfarin. 'As a result, patients would be more likely to develop bleeding as an adverse reaction and in some patients that bleeding into a critical organ (mostly the central nervous system) could be fatal,' the statement says.

The expiration date of the lot MM5767 is June 2014. The product was distributed nationwide in the United States to wholesalers, distributors and retailers from November 2012 to December 2012.

Earlier, Zydus' manufacturing facility at Moraiya in the outskirts of Ahmedabad had received a warning letter from the USFDA in June 2011 on grounds of non-conformity of  the facility with USFDA norms. Following this, the drug regulator had inspected the facility in February last year, and the warning was finally revoked in July 2012.

Other cases of drug recall by Ahmedabad-based companies include that of Claris Lifesciences, which had announced a nationwide recall of all lots of Ciprofloxacin, Metronidazole and Ondansetron from the US voluntarily following a report of its US distributor Sagent Pharmaceuticals and its customer Pfizer that Metronidazole injection USP IV bags were contaminated with fungi.

Claris had entered into a supply deal with Pfizer in 2009 to gain access to markets like the US, Europe and Australia.  Post the recall, Pfizer and Claris had reviewed the supply agreement in the wake of import alert from its Bavla site and the supply agreement was terminated.

Cadila Healthcare stocks ended day's trade at Rs 739.05 on the Bombay Stock Exchange, down 2.17 per cent.