Hydrocodone with Acetaminophen Tabs and Phenobarbital Tabs
February 8, 2011
Qualitest Pharmaceuticals is voluntarily recalling 3 lots of Hydrocodone Bitartrate with Acetaminophen Tablets, USP, 10 mg/500 mg in 60 count bottles (NDC 00603-3888-20; lot numbers T150G10B, T120J10E, and T023M10A) and 3 lots of Phenobarbital Tablets, USP, 32.4 mg in 1000 count bottles (NDC 00603-5166-32; lot numbers T150G10B, T120J10E, and T023M10A). A bottle containing Hydrocodone with Acetaminophen, 10 mg/500 mg (NDC 0603-3888-20) was labeled incorrectly as Phenobarbital 32.4 mg. All of the recalled lots are at risk for labeling errors. Recalled lots were issued nationwide between September 21, 2010 and December 29, 2010.
Use of the mislabeled product could result in serious side effects due to unintentional ingestion of hydrocodone bitartrate and acetaminophen. Inadvertent ingestion of hydrocodone may result in CNS or respiratory depression, coma, or even death. Some consumers may be at increased risk of suffering these side effects, including patients who are opioid-naïve or who are taking other CNS depressants. Inadvertent ingestion of acetaminophen may result in liver damage in certain individuals. Consumers at increased risk of liver damage include those with pre-existing liver disease, those who consume more than three alcoholic beverages per day, and those who are taking other products containing acetaminophen. Consumers are also at risk of adverse effects caused by missing doses of phenobarbital, including loss of seizure control.
Consumers should stop using product from the affected lots. All consumers with Phenobarbital manufactured by Qualitest in their possession are encouraged to check the identity of the tablets against the company’s description (see Press Release). Contact Qualitest for reimbursement information or for answers to other questions related to this recall at 1-800-444-4011. Report any quality concerns or adverse events associated with use of the mislabeled product to the MedWatch program.
Additional information is available at the following links:
- MedWatch Alert:
- Company Press Release:
February 8, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.