Butalbital / Acetaminophen / Caffeine Tablets and Hydrocodone / Acetaminophen Tablets from Qualitest - Recall Due To Potential Mislabeling
June 27, 2011
Qualitest is voluntarily recalling 4 lots each of butalbital 50 mg / acetaminophen 325 mg / caffeine 40 mg tablets in 500-count bottles (NDC 00603-2544-28; lot numbers C0390909A, C0400909A, C0410909A, and C0590909B) and hydrocodone bitartrate 7.5 mg / acetaminophen 500 mg tablets in 1,000-count bottles (NDC 00603-3882-32; lot numbers C0390909A, C0400909A, C0410909A, and C0590909B). A bottle containing butalbital / acetaminophen / caffeine was labeled incorrectly as hydrocodone / acetaminophen. All of the recalled lots are at risk for labeling errors. Recalled lots were distributed nationwide between November 13, 2009 and April 9, 2010.
Use of the mislabeled product could result in serious side effects due to unintentional ingestion of butalbital and caffeine. Inadvertent ingestion of butalbital may cause sedation, lightheadedness, dizziness, nausea; hypersensitivity reactions are possible in susceptible patients. The mislabeled product contains only small amounts of caffeine. Although side effects are less likely to occur, inadvertent ingestion of caffeine may cause tremors, irritability, or sleep disturbance. If the mislabeled product is used to treat chronic pain, patients may experience withdrawal symptoms or increased pain if their hydrocodone doses are missed. No harm is expected from acetaminophen as both products contain this active ingredient.
Consumers should stop using product from the affected lots. All consumers with Hydrocodone / Acetaminophen manufactured by Qualitest in their possession are encouraged to check the identity of the tablets, against the following descriptions:
- Butalbital 50 mg / acetaminophen 325 mg / caffeine 40 mg tablets: white, round tablets, approximately 11 mm in diameter. The imprint reads “2355” on one side and “V” on the reverse side.
- Hydrocodone bitartrate 7.5 mg / acetaminophen 500 mg tablets: capsule-shaped scored tablets, approximately 16.5 mm in length, white with green specks. The imprint reads “3594” on one side and “V” on the reverse side.
Contact Qualitest at 1-800-444-4011, weekdays from 8AM to 5PM Central Standard Time, for reimbursement information or for answers to other recall-related questions. Report any quality concerns or adverse events associated with the mislabeled product to the MedWatch program. Additional information is available at the following links:
- MedWatch Alert:
- Company Press Release:
June 27, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.