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ISSUE: An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found 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 on 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.
BACKGROUND: 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).
RECOMMENDATION: Consumers who have affected product should stop using the product and contact Qualitest at 1-800-444-4011 for reimbursement. Lot numbers can be found on the side of the bottle.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Click here to complete and submit the report Online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit byfax to 1-800-FDA-0178
