March 1, 2011 – On Feb. 16 the Food and Drug Administration (FDA) announced the recall of a lot of Jantoven Warfarin Sodium bottles that may have been mislabeled and contained a stronger dose than the bottle listed. The recall notice from the FDA warns consumers who purchased a bottle of the drug to check their tablets as the two dose strengths are easily identified by color. The 3 mg tablets that should be contained in the bottle are tan, while the erroneously supplied 10 mg tablets are white. The 3 mg tablets also have imprints of WRF, a line, and the number 3 under the line, while the reverse side is imprinted with the numbers 832. The 10 mg tablet has the same imprints, except for a number 10 in place of the 3 on the WRF side. The recall comes after a report was filed where a bottle of 3 mg tablets was found to contain the 10 mg tablets. This is so far an isolated incident, but the entire lot has been recalled as a precaution.
The affected lot, #284081, was distributed by wholesalers, retail chains and pharmacies across the country and has an expiration date of September 2012, NDC #0832-1214-00. The manufacturer, Upsher-Smith Laboratories Inc. of Maple Grove, MN, is contacting the pharmacies and wholesalers the lot was distributed to and arranging for the return of the product. The affected lot was packaged at their Plymouth, MN, plant. This drug mix-up is potentially harmful because a higher dose contained in a lower dose bottle can lead to overdose reactions. Warfarin is an anticoagulant and an excess of the drug can result in complications with bleeding and potentially cause life-threatening hemorrhages.
When a drug company fails to properly label its products it can lead to adverse reactions, overdosing, or other side effects from drug misuse. Warfarin is one of many types of drugs that rely on a constant, steady use to be safe and effective. An abrupt overdose or underdose can cause serious, even fatal consequences. If you or a loved one has been harmed by the negligence of a drug company in their labeling and distribution of a medication you may need to file a dangerous drug claim. A New York dangerous drug claim lawyer can help review your claim and discuss your options to pursue the damages you suffered from the drug manufacturer’s negligence.
Contacting a New York Dangerous Drug Claim Lawyer
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