FDA announces Zydus Pharmaceuticals is recalling some Warfarin tablets due to oversized tablets

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by Jim Orr

Zydus Pharmaceuticals USA Inc. is voluntarily recalling one lot of Warfarin tablets after receiving a consumer complaint of oversized tablets, according to an FDA safety alert. Warfarin is an anticoagulant normally used in the prevention of thrombosis and thromboembolism, the formation of blood clots in the blood vessels and their migration elsewhere in the body respectively.

The dosage and administration of Warfarin sodium must be individualized for each patient. According to official FDA warnings, Warfarin sodium can cause major or fatal bleeding. Bleeding is more likely to occur within the first month. Risk factors for bleeding include high intensity of anticoagulation, age greater than or equal to 65, history of gastrointestinal bleeding, hypertension, cerebrovascular disease, anemia, malignancy, trauma, renal impairment, certain genetic factors, certain concomitant drugs, and long duration of Warfarin therapy.

Zydus Pharmaceuticals is voluntarily recalling one lot of Warfarin 2 mg Tablets, Lot #MM5767, expiration date June 2014 to the retail level. Four tablets of Warfarin 2 mg Tablets, Lot MM5767, have been found to be oversized in one product complaint. The drug is packaged in HDPE Bottle of 1000′s count, which may have been dispensed to patients in smaller bottles.

Ingestion of a greater than intended 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 risk of bleeding is increased if overdosing is repeated continuously on a daily basis.

According to the FDA, consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this particular lot of Warfarin 2 mg Tablets. Anyone with an existing inventory of this particular Lot MM5767 of Warfarin 2 mg Tablets should stop use and distribution, quarantine the recalled lots immediately and call INMAR at 1-800-967-5952 between the hours of 7 a.m. to 4 p.m. CST, Monday through Friday, to arrange for their return. In case patients have tablets of this lot of product, make sure all the tablets are of same size and if unsure, patients should consult their dispensing pharmacy. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

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