One Bottle Leads to Recall

Qualitest Pharmaceuticals issues voluntary recall of some of its products because of a label mix-up

/ Author:  / Reviewed by: Joseph V. Madia, MD

Qualitest Pharmaceuticals issues a voluntary recall because one bottle of its hydrocodone and acetaminophen tablets was labeled as phenobarbital.

Qualitest Pharmaceuticals today issued a voluntary nationwide recall of hydrocodone bitartrate and acetaminophen tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A, and phenobarbital tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A. 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.

As a result of this mix-up, 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 including 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. Additionally, missing doses of phenobarbital could result in loss of seizure control.

No injuries have been reported to date.

Consumers who have the affected product 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
This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration.

These lots were distributed between Sept. 21, 2010 and Dec. 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 (3600) on one side, and debossed (V) on the reverse side; Phenobarbital tablets are small (approximately 6.4 mm in diameter), white, round, biconvex, scored tablets, debossed (5012) and (V) on one side and plain on the reverse side. 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 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 on line, by regular mail, or by fax.

Telephone: 1-800-444-4011
Online: http://www.fda.gov/MedWatch/report.htm
Regular Mail: Use postage-paid FDA form 3500 available at: http://www.fda.gov/MedWatch/getforms.htm Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 1-800-FDA-0178

Reviewed by: 
Review Date: 
February 7, 2011