Zydus Pharmaceuticals US has issued a voluntary recall of one lot of its Warfarin (2 mg) tablets, for being oversized.
Warfarin is an anti-coagulant, or a blood-thinner and prevents blood from clotting. Ingestion of a greater than intended dose of Warfarin, could expose patients to the risk of bleeding and in some patients that bleeding into a critical organ (mostly the central nervous system) could be fatal. The risk of bleeding is increased if overdosing is repeated on a daily basis, an Food and Drug Administration (FDA) note said.
“Zydus has not received any reports of adverse events or any additional product complaint related to this lot to date, but as a precautionary measure, Zydus is recalling lot MM5767 from the distribution,” the note added. Zydus Pharma is part of the Zydus Cadila group.
The recall is small and voluntary, but adds to the list of Indian drug companies and their tryst with the FDA.
FDA woes
Last month, Glenmark Generics recalled multiple lots of anti-asthma drug Montelukast Sodium tablets, because of, what was described as a “fishy smell”. Again in May, another Indian drugmaker RPG Life Sciences was issued a warning letter by the FDA on the violation of good manufacturing practices at its plants in India.
The US regulator suggested that the company get its data up to speed, so that it represented the true quality of its products.
The development would affect new product applications in the US, from the company’s manufacturing facilities that are under the scanner, till the problems are rectified by the company.
Drug companies undertake voluntary recalls when they sense a problem with their product, to build confidence with both the regulator and consumers, said an industry veteran. But when the FDA issues import alerts, as it did with Wockhardt, the nature of the problem becomes more serious.
The most recent, and high-profile, example of an India-based company getting its act wrong with the FDA, is that of Ranbaxy.
Last month, the company ended a long-pending stand-off with the FDA, when it decided to pay $500 million to settle criminal and fraud charges against it in the US.
jyothi.datta@thehindu.co.in