Washington, DC: Qualitest, a subsidiary of Endo Health Solutions, (Nasdaq: ENDP) has issued a nationwide recall for 101 lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. Hydrocodone bitartrate and acetaminophen 10mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.<
It is possible that a number of 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.
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. The product label warns consumers that acetaminophen overdose can potentially cause severe liver damage, at times resulting in liver transplant or death.
The affected lots were distributed between February 20, 2012 and November 19, 2012 to wholesale distributors and retail pharmacies nationwide. Hydrocodone Bitartrate and Acetaminophen Tablets are approximately 16.51 mm in length, pink, capsule-shaped tablets, with "3600"debossed on one side of the tablet and "V"on the other.
