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Jun 13 2013

Oversized 2-mg Warfarin Tablets ( Coumadin) Recalled

Posted in Community Service, Nursing Home, Product Liability

Medical products, improperly manufactured and allowed to bypass the standard pathway for testing and approval, may inadvertently cause extensive injury or death to the patient, says Alabama liability attorney Keith T. Belt .


One lot of 2-mg warfarin tablets made by Zydus Pharmaceuticals is being voluntarily recalled by the company for being oversized. The company announced the recall of lot #MM5767, warning that the oversized pills could lead to an increased pharmacological effect of the drug.

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 risk of bleeding is increased if overdosing is repeated continuously on a daily basis,” a recall notice, issued by the FDA‘s Medwatch Safety Information and Adverse Event Reporting office, reads.

The company noted that it has not received any reports of adverse events or product complaints but is opting to recall this lot as a precautionary measure. A company spokesperson said that there were 960 bottles of pills in the affected lot, each containing 1000 tablets; the pills are typically dispensed to patients in smaller bottles.

The lot in question can be identified by its national drug code (NDC) #6838205310; it was distributed across the US to wholesalers/distributors, retailers, and mail-order providers from November 2012 to December 2012.

If you’ve been prescribed warfarin (Coumadin, Jantoven) to prevent blood clots, you probably already know that this powerful drug can save your life if you’re at risk of or have had blood clots. But you may not realize how serious warfarin side effects can be. Warfarin, especially if taken incorrectly, increases your risk of dangerous bleeding. Warfarin side effects can also include interactions with some foods, prescription medicines and over-the-counter supplements. By Mayo Clinic Staff

Physicians, pharmacies, and hospitals with any of this particular lot in their inventory should stop use and distribution, quarantine the recalled lots immediately, and call 1-800-967-5952 between the hours of 7 am to 4 pm CST, Monday through Friday, to arrange for their return. Patients should make sure all tablets are equal in size and, if unsure, consult their doctors or dispensing pharmacy.

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