Hydrocodone bitartrate and acetaminophen tablets mislabeled as phenobarbital tablets

An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg/500mg, NDC 0603-3888-20, 60 count, was found to be incorrectly labeled with a Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count label, printed with Lot Number T150G10B. Both products are manufactured by Qualitest Pharmaceuticals.

As a result of this mix-up, patients may unintentionally take hydrocodone and acetaminophen tablets, instead of the intended dose of phenobarbital. Unintentional administration of hydrocodone can lead to serious adverse events including respiratory depression, CNS depression, coma and death, especially in opioid-naïve patients and patients on other CNS depressants. Unintentional administration of acetaminophen may result in liver toxicity in patients taking other acetaminophen-containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Additionally, missing doses of phenobarbital could result in loss of seizure control.

The recall includes the following products:

  • Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg/500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A
  • Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A

Recalled lots were distributed between Sept. 21, 2010 and Dec. 29, 2010 to wholesale and retail pharmacies nationwide (including Puerto Rico).

Consumers who have affected product should stop using the product and contact Qualitest at 1-800-444-4011 for reimbursement. 

For more information visit

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm242527.htm