Butalbital, Acetaminophen and Caffeine Tablets, USP
Containing 50 mg butalbital, 325 mg acetaminophen and 40 mg caffeine. Available as white, round shaped tablets, debossed "2355" on one side, and debossed "V" on the reverse side.

Qualitest is notifying all customers who may have received affected product and arranging for the return of any affected product.

Consumers and patients with questions may contact Qualitest at 1-800-444-4011 for more information. Monday through Friday between the hours of 8AM and 5PM CST.

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.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

Reports of adverse reactions or quality problems can also be reported to Qualitest at 1-800-444-4011; Monday through Friday between the hours of 8AM and 5PM CST.

____________

Resources:

Press release. "Qualitest Pharmaceuticals Issues Voluntary, Nationwide Retail Level Recall of Four Lots of Butalbital, Acetaminophen, and Caffeine Tablets, USP 50mg/325mg/40mg and Four Lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg/500mg" Food and Drug Administration. June 24, 2011.

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© Teri Robert, 2011
Last updated June 27, 2011