Qualitest issued a voluntary recall of three lots (11,000 bottles) of its hydrocodone with acetaminophen product on February 5, 2011. One bottle was found to be mislabeled, causing the medication to be identified as phenobarbital. According to the manufacturer, the error was discovered as a printing error and immediately corrected. About 5,000 bottles were found in the warehouse prior to pharmacy shipment which leaves 6,000 bottles out in the marketplace. Qualitest and Endo Pharmaceuticals, Inc., notified the Food and Drug Administration (FDA) and wholesale and retail pharmacies.
If you are taking generic hydrocodone or phenobarbital, please check your lot numbers immediately. These lots were distributed between September 21, and December 29, 2010, to wholesale and retail pharmacies nationwide (including Puerto Rico). Affected lots are:
- hydrocodone bitartrate and acetaminophen tablets (10mg / 500mg): Lot numbers T150G10B, T120J10E and T023M10A
- phenobarbital tablets (32.4 mg): Lot numbers T150G10B, T120J10E and T023M10A
Qualitest is notifying all customers who may have received affected product and arranging for the return of any affected product.
Consumers with questions may contact Qualitest at 1-800-444-4011 for more information.
printer-friendly version