Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg Recalled

September 11, 2012

Qualitest, a subsidiary of Endo Health Solutions, has issued a voluntary, nationwide retail level recall for one lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. Bottles from the affected lot may contain tablets that have a higher dosage of acetaminophen. As a result, it is possible that you could take more than the intended acetaminophen dose. Taking too much acetaminophen can result in liver toxicity, especially in:

  • Patients on other medications which contain acetaminophen,
  • Patients with liver dysfunction, or
  • People who consume more than 3 alcoholic beverages a day.

The affected lot, C1440512A, was distributed between May 14 and Aug. 3, 2012 to wholesale distributors and retail pharmacies nationwide. If you have lot C1440512A, you should contact Qualitest at 1-800-444-4011.

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

For more information, please read the MedWatch safety alert, which includes a link to the FDA Drug Safety Communication.