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Painkiller pills recalled due to higher dosage risk

By Tim Sandle     Jan 3, 2013 in Health
The pharmaceutical company Mylan has voluntarily recalled three types of painkiller tablets due to the risk that the tablets are more potent than the label indicates. The risk is that consumers could overdose.
The tablets being recalled are hydrocodone bitartrate and acetaminophen, USP 10 mg/500 mg, distributed by the pharma company Mylan. Hydrocodone bitartrate and acetaminophen are indicated for the treatment of moderate to moderately severe pain. According to the U.S. Food and Drug Administration, the increased content of hydrocodone could result in more severe or frequent side effects, such as sedation or respiratory depression, especially in elderly patients who have severe kidney or liver impairment, or patients taking interacting medications, e.g., other sedating medication or certain antidepressants.
As a sign of how inter-linked the prescription drugs world is, the tablets were originally made by Qualitest Pharmaceuticals, a subsidiary of Endo Health Solutions. Confusingly, the tablets were then repackaged by Mylan under the UDL Laboratories Inc. label.
The alarm that the tablets might quite not be right was sounded by Qualitest, who voluntarily recalled 101 lots of hydrocodone bitartrate and acetaminophen tablets. The company stated in its press release, that a small number of tablets from the affected lots may exceed the weight requirement and could exceed the label claim potency requirements for the ingredients hydrocodone bitartrate and acetaminophen.
The affected lots were distributed between Feb. 20 and Nov. 19, 2012, to wholesale distributors and retail pharmacies in the United States.
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