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Qualitest Pharmaceuticals, a generic drug manufacturer, has recalled about 11,000 bottles of its hydrocodone with acetaminophen tablets.
The recall was announced February 5 after one bottle was found to be mislabeled, causing the medication to be identified as phenobarbital. As a result of the mix-up patients may unintentionally take hydrocodone and acetaminophen tablets, instead of the intended dose of phenobarbital.
Consumers who have affected product should stop using the product and contact Qualitest at 1-800-444-4011 for reimbursement. The lot number can be found on the side of the bottle.
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.
These lots were distributed between Sept. 21 and Dec. 29, 2010, to wholesale and retail pharmacies nationwide (including Puerto Rico).
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 and wholesale and retail pharmacies of the recall.
No injuries have been reported to date.
Adverse reactions or quality problems experienced with the use of this product may be reported to the manufacturer or to FDA's MedWatch Adverse Event Reporting program either on line, by regular mail, or by fax. -- Telephone: 1-800-444-4011 -- Online: www.fda.gov...
Originally posted by Kangaruex4Ewe
reply to post by Underworlds
The pharmacy should have it on record for you. They have (atleast mine did) the lot # in the database, especially since it is a controlled substance.