Qualitest Recalls Incorrectly Labeled Tablets

Qualitest Pharmaceuticals just issued a nationwide, retail-level <"http://www.yourlawyer.com/practice_areas/defective_drugs">drug recall of Butalbital, Acetaminophen, and Caffeine Tablets, the U.S. Food and Drug Administration (FDA), just announced.

A 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.

To date, no injuries have been reported; however, unintentional administration of butalbital could result in sedation, lightheadedness, dizziness, and nausea. Patients allergic to butalbital could experience a hypersensitivity reaction. Side effects due to caffeine are less likely, due to the small amounts in this formulation; however, individuals with a sensitivity to caffeine may experience tremors, irritability, and difficulty sleeping. Patients receiving hydrocodone for chronic pain might experience worsening pain and withdrawal symptoms.

The impacted lots were distributed between November 13, 2009 and April 9, 2010 to wholesale and retail pharmacies nationwide and in Puerto Rico. The recall includes:

• 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

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 and are white, round-shaped tablets, debossed with “2544” on one side and “V” on the reverse. Hydrocodone Bitartrate and Acetaminophen Tablets are approximately 16.5 mm in length and are white with green specs, round, capsule shaped, scored tablets, debossed with “3594” and “V” on one side; the reverse side is plain.

Patients who have filled prescriptions for Qualitest’s Hydrocodone Bitartrate and Acetaminophen are asked to check their tablets. Qualitest said it is notifying customers who may have received the recalled product and is arranging for the products’ return. Qualitest can be reached, toll-free, at 1.800.444.4011 Monday through Friday between 8:00 a.m. and 5:00 p.m., Central Standard Time (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; by 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; or by Fax: 1-800-FDA-0178.

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