Safety Alerts & Recalls

What does this mean?

Because the recalled bottles may contain incorrect tablets, patients may unintentionally take a medicine that is not meant for them. Unintended use of the wrong medicine could result in symptoms such as sedation, lightheadedness, dizziness, nausea, tremors, irritability and difficulty sleeping. Patients who were receiving hydrocodone for chronic pain might experience worsening pain and withdrawal symptoms as a result of this substitution. However, no injuries have been reported to date.

If you take Butalbital, Acetaminophen, and Caffeine Tablets, 50mg/325mg/40mg tablets or Hydrocodone Bitartrate and Acetaminophen Tablets, 10mg / 500mg, please check your prescription bottle to see if you medicine was made by Qualitest. Your prescription label should have the manufacturer listed on it, usually indicated next to the letters "MFG".

If your tablets are made by Qualitest, make sure you have received the correct tablets. Butalbital, Acetaminophen, and Caffeine Tablets, 50mg/325mg/40mg tablets from Qualitest are white, round shaped tablets, with “2355” on one side, and “V” on the other side. Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/500 mg from Qualitest are white with green specks, capsule-shaped, scored tablets, with “3594” on one side and “V” on the other side.

If you think your medicine is involved in the recall or you are not sure, please take your prescription bottle and medicine to your pharmacist to examine. You can also contact Qualitest at 1-800-444-4011, Monday through Friday between the hours of 8AM and 5PM CST if you have any other questions.

If you have any other concerns about your medicine or think you are experiencing side effects, please follow up with your doctor or other healthcare provider.

Healthcare providers 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 Four Lots of Butalbital, Acetaminophen, and Caffeine Tablets and Four Lots of Hydrocodone Bitartrate and Acetaminophen Tablets

Qualitest Pharmaceuticals has issued a voluntary nationwide recall of Butalbital, Acetaminophen, and Caffeine Tablets, 50mg/325mg/40mg, and Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5mg/500mg. The lots are being recalled because an individual bottle of Butalbital, Acetaminophen, and Caffeine Tablets, 50mg/325mg/40mg, 500 count was found incorrectly labeled with a Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5mg/500mg, 1000 count label.

The following lots are being recalled: Butalbital, Acetaminophen, and Caffeine Tablets, USP, 50mg/325mg/40mg, NDC 0603-2544-28 500 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg / 500mg, NDC 0603-3882-32, 1000 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B

This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration.

Butalbital, Acetaminophen, and Caffeine is used to treat migraines. These combination tablets are made by many different manufacturers and are sold under other names including Esgic-Plus and Fioricet. Hydrocodone Bitartrate and Acetaminophen is used for moderate to severe pain. These combination tablets are made by many different manufacturers and are 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 Butalbital, Acetaminophen, and Caffeine Tablets, 50mg/325mg/40mg and Hydrocodone Bitartrate and Acetaminophen Tablets, 10mg / 500mg from Qualitest. No other Butalbital, Acetaminophen, and Caffeine or Hydrocodone Bitartrate and Acetaminophen products are involved in this recall.

For more information, please visit: more information here

Source: FDA
Publication Date: 2011-06-28
Last Updated: 2011-06-28

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