Qualitest pulls out-of-spec pain drug
The firm said tablets in the withdrawn lot - hydrocodone Bitartrate and Acetaminophen, USP 10 mg/500 mg, NDC 0603-3888-21, 100 count, Lot Number C1440512A, expiry date 12/13 – could contain a higher dose of the painkiller and pose a risk to patient health.
“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” it said, adding that no injuries have been reported.
The company – which is a subsidiary of Endo Health Solutions – stressed that the withdrawal is a precautionary measure and that it has informed the US Food and Drug Administration.
