Two prescription medications are being recalled by Qualitest due to a report that a bottle was labeled to contain one medication but instead contained the other drug. The recall involves hydrocodone bitartrate and acetaminophen tablets, an opioid analgesic and antitussive painkiller also known by the brand name Vicodin, and phenobarbital tablets, a barbiturate used to treat and prevent seizures and sleep disorders.

The mix-up may lead patients to unintentionally take hydrocodone and acetaminophen tablets instead of the intended dose of Phenobarbital, which can lead to serious adverse reactions including respiratory depression, CNS depression, coma and death, especially in patients who are not used to taking opioids and patients on other CNS depressants.

Unintentional administration of acetaminophen could also result in liver toxicity in patients on other acetaminophen-containing medications, in patients with liver dysfunction, or in people who consumer more than three alcoholic beverages a day. Additionally, missing doses of Phenobarbital could result in loss of seizure control.

High doses of acetaminophen have been linked to liver damage. Recently, the Food and Drug Administration (FDA) asked manufacturers of prescription drugs that contain acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams in each tablet or capsule and to update their safety information to include a warning for the risk of severe liver toxicity.

The following products are affected by the recall:

• 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

The recalled lots were distributed between Sept. 21, 2010 and Dec. 29, 2010 to wholesale and retail pharmacies nationwide, including Puerto Rico. Qualitest has notified pharmacies. Consumers who have the recalled drugs in their possession should stop using the product and call Qualitest at 1-800-444-4011 for reimbursement.

Any side effects with these or any other medications should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.