BETHESDA, MD 13 Jun 2013—Zydus Pharmaceuticals USA Inc. on Monday announced a recall of lot MM5767 of the company's warfarin 2-mg tablets because four of the tablets were reported to be oversize, according to a press release circulated Wednesday evening by FDA.
The company said, as of Monday, it had not received any reports of adverse events from ingestion of tablets from lot MM5767.
But ingestion of a larger-than-intended warfarin dose, the company said, could result in a patient being more likely to bleed.
Lot MM5767 was supplied in 1000-count bottles and distributed to wholesalers, distributors, retail pharmacies, and mail-order pharmacies in November and December 2012, the company said.
Anyone with an inventory of warfarin 2-mg tablets from Zydus's lot MM5767 is being asked to stop using and distributing them and to immediately call Inmar at 800-967-5952, between 7 a.m. and 4 p.m. CST Monday through Friday, to arrange for the tablets' return.
Patients with warfarin 2-mg tablets from lot MM5767 are being advised to make sure all those tablets are of the same size and consult the dispensing pharmacy if unsure.
Product safety questions should be directed to Zydus's drug safety and medical affairs team at 877-993-8779 (select option 2).
The company wants consumers to contact their physician or health care provider if they have ingested warfarin 2-mg tablets from lot MM5767 and "experienced any problems that may be related."
Zydus Pharmaceuticals USA is part of Zydus Cadila, which operates as Cadila Healthcare Ltd. and is headquartered in India. Cadila Healthcare manufactured the warfarin tablets.