Qualitest Pharmaceuticals issued a voluntary nationwide retail level recall of Butalbital, Acetaminophen, and Caffeine Tablets USP, 50mg/325mg/40mg, and Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg/500mg. This recall was initiated because an individual bottle of Butalbital, Acetaminophen, and Caffeine Tablets USP, 50mg/325mg/40mg, 500 count was found incorrectly labeled with a Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg/500mg, 1000 count label, printed with Lot Number C0590909B. Lots C0390909A, C0400909A, C0410909A used the same stock inventory of labels as Lot C0590909B and are potentially impacted.
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. Side effects due to caffeine are less likely, due to the small amounts in this formulation, however, those individuals with a 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. No injuries have been reported to date.
The recall includes the following products:
* 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.
These lots were distributed between Nov. 13, 2009 and April 9, 2010 to wholesale and retail pharmacies nationwide. Lot numbers can be found on the side of the manufacturer's bottle.
Butalbital, Acetaminophen, and Caffeine Tablets are (approximately 11.0 mm in diameter), white round-shaped tablets, debossed (2544) on one side, and debossed (V) on the reverse side; Hydrocodone Bitartrate and Acetaminophen Tablets are (approximately 16.5 mm in length), white with green specks, round, capsule shaped, scored tablets, debossed (3594) and (V) on one side and plain on the reverse side. All patients who have filled prescriptions of Hydrocodone Bitartrate and Acetaninophen manufactured by Qualitest, are asked to double check the identity of their tablets. 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 8 a.m. and 5 p.m. 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.htm1
* Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm2. 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 8 a.m. and 5 p.m. CST.