Mislabeled Drugs Recalled by Qualitest Pharmaceuticals

Qualitest Pharmaceuticals just issued a voluntary nationwide drug recall of some of its Hydrocodone Bitartrate and Acetaminophen Tablets and its Phenobarbital Tablets, the U.S. Food and Drug Administration (FDA) just announced.

An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg/500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled with a Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count label, printed with Lot Number T150G10B. Lots T120J10E and T023M10A used the same stock inventory of labels as Lot T150G10B and are potentially impacted.

Patients may unintentionally take Hydrocodone and acetaminophen tablets instead of the intended dose of Phenobarbital. Unintentional administration of Hydrocodone can lead to serious adverse events “respiratory depression, CNS depression, coma and death” especially in opioid naïve patients and patients on other CNS depressants. Unintentional administration of acetaminophen may result in liver toxicity in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than three alcoholic beverages a day. Missing Phenobarbital doses could result in loss of seizure control. No injuries have been reported, to date.

Consumers in possession of these defective drugs should stop using the product and contact Qualitest at 1-800-444-4011 for reimbursement. The lot number can be found on the side of the bottle. The recall includes the following products:

• Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A
• Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A

These lots were distributed between September 21, 2010 and December 29, 2010 to wholesale and retail pharmacies nationwide, including Puerto Rico. Lot numbers can be found on the side of the bottle.

Hydrocodone Bitartrate and Acetaminophen Tablets are large “approximately 16.5 mm in length” pink, capsule-shaped tablets, debossed with 3600 on one side and V on the reverse side. Phenobarbital Tablets are small “approximately 6.4 mm in diameter” white, round, biconvex, scored tablets, debossed with 5012 and V on one side only. All patients who have filled prescriptions of Phenobarbitol manufactured by Qualitest are asked to double-check the identity of their tablets.

Qualitest is notifying all customers who may have received affected product and is also arranging for the return of any affected product. Consumers with questions may contact Qualitest at 1-800-444-4011 for more information.

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 online, by regular mail, or by fax: Telephone: 1-800-444-4011; Regular Mail: Use postage-paid FDA form 3500 available onine. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787; or Fax: 1-800-FDA-0178.