Recall of pain medicine

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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.

Although 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 recall.

For more information, please visit:

http://www.mediguard.org/r/04FBwXoAFUTU

and

http://www.mediguard.org/r/0ThyPKYP6edA

****

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 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.

For updated risk ratings on all of your registered medications, or to update

your medication list, please log into your profile

(https://www.mediguard.org/user).

You can also reach your profile by clicking on the link in the top right corner

of any page on our web site.

****

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DISCLAIMER

MediGuard is not intended to be a substitute for professional medical advice.

MediGuard cannot and does not take into consideration every possible interaction

or account for individual responses to medicine. Different individuals may

respond to medication in different ways. The absence of a warning for a given

drug or drug combination in no way should be construed to indicate that the drug

or drug combination is safe, effective, or appropriate for any given patient.

Always seek the advice of a qualified health provider with any questions you may

have before making any changes to your treatment. The use of the MediGuard site

and its content is at your own risk. © 2011 iGuard, Inc.. All rights reserved.

iGuard, Inc., 66 Witherspoon St #262, Princeton, NJ 08542.

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