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FDA Issues Recall on Acetaminophen and Hydrocodone Tablets

Feb 6, 2013 | Drug Injury

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Feb. 6, 2013

The U.S. Food and Drug Administration (FDA) recently announced a voluntary recall affecting three lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg (Lots 3037841, 3040859 and 3042573). According to a press release, the recall is being conducted due to a miscalculation of the amount of active ingredient each tablet may contain.

The drugs were manufactured by Qualitest Pharmaceuticals, Inc. and were then repackaged and distributed by Mylan Institutional. Testing of the drugs determined that some tablets in the affected lots were above the standard weight limit that was established for the product, meaning the medications may contain more active ingredient than they are supposed to.

Ingesting too much of either of the medications could result in a potential Drug Injury, such as acute liver toxicity or failure, potentially leading to death if left untreated. Those suffering from liver dysfunction, consuming more than three alcoholic beverages per day, or taking other medications containing acetaminophen have the highest risk of injury.

The FDA has stated that anyone in possession of the affected product should halt use of the medications immediately.

The Indiana Personal Injury Attorneys with the law firm of Stewart & Stewart Injury Lawyers recognize how dangerous taking a medication that has been recalled can be, and they encourage anyone who has been harmed by such a product to discuss their legal rights with an attorney.

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