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HUNTSVILLE, Ala. — Qualitest Pharmaceuticals has announced a voluntary nationwide retail-level recall of butalbital, acetaminophen and caffeine tablets (50mg/325mg/40mg) and hydrocodone bitartrate and acetaminophen tablets (7.5mg/500mg).
The drug maker said late Friday that it initiated the recall, made with the knowledge of the Food and Drug Administration, because an individual 500-count bottle of the butalbital, acetaminophen and caffeine tablets was incorrectly given a label for a 1,000-count bottle of the hydrocodone bitartrate and acetaminophen tablets.
Product lots affected in the recall were distributed between Nov. 13, 2009. and April 9, 2010. to wholesale and retail pharmacies nationwide, including Puerto Rico, according to Qualitest. The recall includes the following products:
• Butalbital, acetaminophen and caffeine tablets (50mg/325mg/40mg, 500 count), NDC 0603-2544-28 in lot numbers C0390909A, C0400909A, C0410909A and C0590909B.
• Hydrocodone bitartrate and acetaminophen tablets (7.5mg / 500mg, 1,000-count), NDC 0603-3882-32, in lot numbers C0390909A, C0400909A, C0410909A and C0590909B.
Qualitest said no injuries have been reported to date in connection with the pain relief medications affected by the recall.
"Because the recalled bottles may contain incorrect tablets, patients may unintentionally take butalbital and caffeine instead of hydrocodone (acetaminophen is in both preparations). Unintentional administration of butalbital could result in symptoms such as sedation, lightheadedness, dizziness, and nausea. Additionally, patients with an allergy to butalbital could experience a hypersensitivity reaction," the company stated. "Side effects due to caffeine are less likely, due to the small amounts in this formulation; however, those individuals with sensitivity to caffeine may experience symptoms such as 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."
Patients who have filled prescriptions of hydrocodone bitartrate and acetaninophen manufactured by Qualitest are being advised by the company to double-check the identity of their tablets. Qualitest said it also is notifying all customers who may have received affected products and arranging for the return of any affected product.
