Recalls

Drug maker recalls errant ‘super potent’ prescription painkiller

watson pharmaceuticals logo Drug maker recalls errant super potent prescription painkillerWatson Pharmaceuticals is recalling two lots of the painkiller hydrocodone bitartrate and acetaminophen tablets after a customer reported receiving tablets that were thicker and a darker shade than the other tablets. Watson says it is possible that some tablets from lots 519406A and 521759A exceed the weight specifications and may contain higher than indicated amounts of the ingredients hydrocodone bitartrate and/or acetaminophen.

The recall comes two weeks after Qualitest, a subsidiary of Endo Health Solutions, issued a recall of hydrocodone bitarate and acetaminophen because the tablets could contain a higher doseage of the active ingredients.

Hydrocodone bitarate and acetaminophen pills are prescription medications used to relieve moderate to moderately severe pain.

The super potent pills have the potential to cause serious or fatal reactions. Higher-than-indicated doses of acetaminophen could result in liver toxicity, especially in patients on other acetaminophen-containing medications, patients with liver dysfunction, or in people who consume more than three alcoholic beverages a day.

Acetaminophen overdose can cause live damage that, at times, can result in the need for liver transplant. It can also be deadly.

Higher doses of hydrocodone bitartrate could increase the severity or frequency of side effects, such as sedation or respiratory depression, particularly elderly patients, those with severe kidney or liver impairment, or those taking medications that can interact with the drug, such as sedatives or antidepressants.

The latest recall affects Watson’s hydrocodone bitartrate and acetaminophen 10mg/500 mg tablets in 500-count bottles, NDC 00591-0540-05, Lot Numbers 519406A and 521759A both with the expiry date April 2014.

Any side effects with this drug should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Sources:
FDA
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