Pain Reliever Recalled for Excess Acetaminophen Doses

Topics: Patient safety and Prescription label

Qualitest, a subsidiary of Endo Health Solutions, issued a voluntary recall of 101 lots of hydrocodone bitartrate and acetaminophen tablets, USP 10 mg/500 mg. Bottles of the affected lots may contain tablets that have a higher dosage of acetaminophen than what is indicated on the label. Consumers taking the painkiller could be at risk of acetaminophen overdose. Excess doses of acetaminophen can lead to liver toxicity, among other adverse events.

The affected lots were distributed between February 20, 2012 and November 19, 2012, to wholesale distributors and retail pharmacies nationwide. The recall applies to the following National Drug Code (NDC) numbers and lot numbers beginning with the letter C:

  • 0603-3888-16
  • 0603-3888-20
  • 0603-3888-02
  • 0603-3888-21
  • 0603-3888-22
  • 0603-3888-26
  • 0603-3888-04
  • 0603-3888-28
  • 0603-3888-32