Zydus Pharmaceuticals USA Inc. is voluntarily recalling one lot of warfarin 2 mg tablets, lot # MM5767, June expiration date of 2014 for the retailer. Four tablets of warfarin 2 mg tablets, lot MM5767, were found to be oversized in the complaint of a product.
Eating a larger than intended to dose of warfarin, could lead to a greater pharmacological effect of warfarin. As a result, patients would be more likely to develop bleeding as an adverse reaction and in some patients the bleeding in a critical organ (primarily the central nervous system) can be fatal. The risk of bleeding is increased if the overdose is repeated continuously on a daily basis.
Zydus did not receive reports of adverse events or any additional product complaint related to this very date, but as a precaution, Zydus is recalling Lot distribution MM5767.
The product is used as a prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE), prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or heart valve replacement and reduction of the risk of thromboembolic events, such as stroke or systemic embolization after myocardial infarction, myocardial infarction (MI) recurrent and death. The product is packaged in HDPE bottles 1000 count, which may have been dispensed to patients in smaller bottles. Single lot affected warfarin 2 mg tablets being recalled is very MM5767.
The product can be identified by its 6838205310 of # NDC. The product was distributed nationwide in the United States for wholesalers/distributors, retailers and mail order providers, November 2012 to December 2012.
Zydus notified their direct account customers by sending the letter of formal notice of recall by FedEx next day air service and works with clients to arrange for product return.
Someone with an existing inventory in this particular MM5767 lot of 2 mg of warfarin tablets should discontinue use and distribution, quarantine lots recalled immediately and call 1-800 in INMAR-967-5952 between the hours of 07 the 4:0 pm CST, Monday through Friday, to arrange its return. In the case of patients have tablets this batch of product, make sure all the pills are the same size and if not sure, patients should consult their dispensing pharmacy.
If you have any question about the product safety issue, so please call Zydus pharmaceuticals drugs safety/Medical Affairs at 1-877-993-8779, option # 2. Consumers should contact their physician or health care provider if they have experienced problems may be related to taking or using this batch of warfarin 2 mg tablets.
Adverse reactions or quality problems with the use of this product may be reported to the FDA's MedWatch adverse event Reporting program either online, by post or by fax.
Online: http://www.fda.gov/medwatch/report.htm1 [1]
Regular mail: use postage-paid pre-addressed FDA form 3500, available at:
http://www.FDA.gov/medwatch/getforms.htm2 [2]. Mail to the address on the pre-addressed form.
Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the u.s. Food and Drug Administration.
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