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HUNTSVILLE, Ala. — Qualitest has voluntarily recalled 101 lots of hydrocodone bitartrate and acetaminophen tablets (10 mg/500 mg) because of the potential for oversized pills.
The Endo Health Solutions subsidiary said late Thursday that some tablets from the affected lots may exceed the weight requirement and could exceed the label claim potency requirements for the ingredients of hydrocodone bitartrate and acetaminophen.
In particular, the company noted, bottles from the affected lots may contain tablets with a higher dosage of acetaminophen and, consequently, consumers could take more than the intended acetaminophen dose, especially if they are taking other medicine containing acetaminophen. The company also said taking a higher dose of hydrocodone than intended could result in an increase in the severity or frequency of side effects, including those taking other sedating medications or certain antidepressants.
Qualitest said the affected product lots include 30-, 60-, 90-, 100-, 120-, 150-, 180-, 500- and 1,000-count bottles. The lots were distributed between Feb. 20 and Nov. 19, 2012, to wholesale distributors and retail pharmacies nationwide.
Hydrocodone bitartrate and acetaminophen 10mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.
