Qualitest Generic Vicodin Recall Expanded Due to Risk of Overdose

A recall for generic Vicodin tablets manufactured by Qualitest has been expanded from one lot of 100-count bottles to include a total of 101 lots that may contain pills with too much of the active ingredients, including hydrocodone bitrate and acetaminophen.

The FDA announced the expanded Qualitest generic Vicodin recall on December 7, indicating that a number of tablets from the affected lots may exceed the weight requirement and could exceed the label claim potency requirements for acetaminphen or hydrocodone bitrate.

Vicodin (hydrocodone and acetaminophen) is a powerful opioid painkiller approved to relieve moderate to severe pain. The brand name version of the drug and generic equivalents that use the same active ingredients are prescribed more than 100 million times a year in the United States.

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Although there have been no reported injuries associated with the recalled Vicodin generic tablets, this may pose a risk of serious and potentially life threatening injuries.

High doses of acetaminophen may increase the risk of an overdose that causes liver damage or liver failure. There is an especially high risk for individuals who may be taking other acetaminophen medications, such as Tylenol, individuals with pre-existing liver dysfunction and those who consumer more than 3 alcoholic beverages a day.

Overdoses of acetaminophen result in more than 50,000 emergency room visits, 25,000 hospitalizations and over 450 deaths annually, according to data previously provided by the FDA.

Taking too much hydrocodone can cause increased sedation and respiratory depression, especially in patients suffering from kidney or liver problems.

The hydrocodone component is an opioid painkiller, also known as an opioid pain reliever (OPRs).  It is part of a class of analgesis medications that also includes methadone, oxycodone and morphine. All are powerful controlled substances that can be cause respiratory depression, extreme sedation and death if taken in high quantities.

The recall affects 101 lots of Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg with 30, 60, 90, 100, 120, 150, 180, 500, and 1,000 tablet bottles. The associated NDC numbers are listed in the recall notice. The affected lots were distributed between February 20, 2012 and November 19, 2012. The tablets are pink, capsule-shaped and have “3600” debossed on one side and “V” debossed on the other.

This recall is not the first time Qualitest has had manufacturing problems with their generic Vicodin.  The drug maker issued another generic Vicodin recall in June 2011, due to a mix-up that resulted in the labels of generic Vicodin and generic Fioricet being swapped. That recall affected four lots of each drug.

Qualitest, a subsidiary of Endo Health Solutions, is recommending that consumers who have bottles from the affected lots contact the company by calling (800) 444-4011. If they are unsure they have bottles affected by the recall they should contact their pharmacy or health care professional.


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