Hydrocodone Bitartrate and Acetaminophen Tablets 7.5mg/500 mg

AUDIENCE: Consumer, Health Professional

ISSUE: Qualitest, a subsidiary of Endo Health Solutions, issued a voluntary nationwide recall for 101 lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. Bottles from the affected lots may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended acetaminophen dose.

Unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day.

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.

BACKGROUND: Hydrocodone bitartrate and acetaminophen 10mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.

The affected lots, were distributed between Feb. 20, 2012 and Nov. 19, 2012 to wholesale distributors and retail pharmacies nationwide.