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Recall Of Generic Vicodin: Fda Announces Recall Over Concerns Of Overdose

December 11, 2012

Recall Of Generic Vicodin: FDA Announces Recall Over Concerns Of Overdose

In the wake of the news of recalls and poor production methods and conditions out of Ranbaxy Laboratories in India, the U.S. Food and Drug Administration has announced the recall of another popular generic medication over concerns that it could lead to overdose. The medication in question is a generic form of Vicodin produced by Qualitest, which is a subsidiary of Endo Health Solutions, according to a report by the FDA.

As it is, Vicodin is a combination of acetaminophen and hydrocodone, and it is prescribed by physicians and medical providers for treating severe pain. Because it is also an opioid-based painkiller and the body becomes accustomed to the pain relief that it provides, Vicodin and its related generic forms can be an addictive medication, which increases the chances of overdose as the body builds a stronger tolerance to the drug. In the case of this recall, that danger is even greater because the Qualitest pills potentially contain higher levels of acetaminophen and/or hydrocodone.

This recall has now been expanded from one initial lot of pills to 101 lots of hydrocodone bitartrate and acetaminophen tablets, USP 10 mg/500 mg. If patients are taking these specific pills, unaware of the higher ingredient levels, the results could be severely dangerous, with liver toxicity and dysfunction as extreme possibilities. According to the FDA:

“Taking a higher dose of hydrocodone than intended could result in an increase in the severity or frequency of side effects, such as sedation or respiratory depression, particularly in patients who are elderly, have severe kidney or liver impairment, or are also taking interacting medications, for example other sedating medications or certain antidepressants.”

The lots included in this recall were distributed by Qualitest between Feb. 20 and Nov. 19 this year, and the FDA is urging patients who may be using this generic form of Vicodin to stop using the drug immediately and contact Qualitest immediately at (800) 444-4011.

 

 

 

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