Safety Alerts & Recalls

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.

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: more information here

and

more information here

Source: FDA
Publication Date: 2011-02-07
Last Updated: 2011-02-07

Visit the medication page for the following drugs:

Share your story Share your story! Tell us how MediGuard has helped you or someone you love. Mobile graphic Download the MediGuard Mobile App to manage your prescription and over-the-counter medications, for free. Registration Info Taking multiple medications puts you at risk for possible drug-drug interactions Registration Info Monitor the medical treatment of you and your loved ones.