Qualitest Recalls Hydrocodone Bitartrate And Acetaminophen Tablets Because of Incorrect Package Labeling

The recalled lots of Hydrocodone Bitartrate and Acetaminophen Tablets, 10mg /
500mg from Qualitest Pharmaceuticals were distributed between September 21, 2010
and December 29, 2010 to wholesale and retail pharmacies nationwide (including
Puerto Rico). Patients who have received prescriptions for Hydrocodone
Bitartrate and Acetaminophen Tablets, 10mg / 500mg between September 2010 and
February 2011 may be affected by the recall.

If you take Hydrocodone
Bitartrate and Acetaminophen Tablets, 10mg / 500mg, you may wish to check your
medicine to see if it was made by Qualitest. The manufacturer's name is often
listed on the prescription label. If your Hydrocodone Bitartrate and
Acetaminophen Tablets, 10mg / 500mg are made by Qualitest, they should be large,
pink, capsule-shaped tablets, with (3600) imprinted on one side, and a (V)
imprinted on the reverse side.

If you think your tablets are made by
Qualitest and possibly involved in the recall, or if you think your tablets look
different than what you normally receive, take your prescription to your
pharmacist to examine. Consumers with questions may also contact Qualitest at
1-800-444-4011 for more information.

If you take Hydrocodone Bitartrate
and Acetaminophen and have medical concerns, please follow up with your
doctor.

Healthcare professionals and patients are encouraged to report
adverse events or side effects related to the use of this medicine to the FDA's
MedWatch Adverse Event Reporting Program by telephone at 1-800-332-1088, by fax
at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD
20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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