Qualitest Recalls Hydrocodone Bitartrate And Acetaminophen Tablets Because of Incorrect Package Labeling
Qualitest Recalls Hydrocodone Bitartrate And Acetaminophen Tablets Because
of Incorrect Package Labeling
Qualitest Pharmaceuticals has issued a voluntary nationwide recall of
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC
0603-3888-20, 60 count, lot numbers T150G10B, T120J10E and T023M10A. These lots
of Hydrocodone Bitartrate and Acetaminophen Tablets are being recalled because
an individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP
10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled as
Phenobarbital Tablets USP, 32.4mg, NDC 0603-5166-32, 1000 count.
there are no reports of this label mix-up affecting the recalled lots of
Hydrocodone Bitartrate and Acetaminophen Tablets, 10mg / 500mg, Qualitest is
being cautious and recalling the lots of Hydrocodone Bitartrate and
Acetaminophen Tablets and Phenobarbital Tablets that are possibly impacted by
the label mix-up.
Hydrocodone Bitartrate and Acetaminophen is used for
moderate to severe pain. It is made by many different manufacturers and is also
sold under other names such as Anexsia, Co-Gesic, Lortab, Norco, and Vicodin.
This recall alert only applies to the select lots of the generic Hydrocodone
Bitartrate and Acetaminophen Tablets, 10mg / 500mg from Qualitest. No other
Hydrocodone Bitartrate and Acetaminophen products are involved in this
For more information, please
WHAT DOES THIS MEAN?
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
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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