Mislabeling Triggers Tablet Recall by American Health Packaging

Jul 22, 2014
By PharmTech Editors

American Health Packaging has recalled one lot of ibuprofen tablets, USP, 600 mg in a hospital unit dose presentation, that may contain individual blistered doses labeled as oxcarbazepine tablets. In addition, the company has recalled one lot of oxcarbazepine tablets, 300 mg. These voluntary recalls are the result of mislabeled inner unit dose blister packaging, which could result in patients receiving ibuprofen and missing their scheduled dose of oxcarbazepine.

The company reports that it has received one customer complaint, which resulted in the investigation and recall of these drug products. AHP says it has not received any adverse event reports attributable to the mislabeled drug.

Ibuprofen 600 mg tablets are indicated for the relief of mild to moderate pain; for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis; and treatment of primary dysmenorrhea. Oxcarbazepine is used for treating certain types of seizures in patients with epilepsy. Failure to receive the proper dose of oxcarbazepine could increase the chances of having a seizure.

Affected products as follows:

  • Cartons of 100 count (10x10) Hospital Unit Dose blisters of AHP Ibuprofen Tablets, USP, 600 mg, with outer carton NDC#: 68084-703-01 and individual dose NDC#: 68084-703-11, Lot #142588, Expiration Date, 01/2016.
  • Cartons of 100 count (10x10) Hospital Unit Dose blisters of AHP Oxcarbazepine Tablets, 300 mg, with outer carton NDC#: 62584-143-0 and individual dose NDC#: 62584-143-11, Lot #142544, Expiration Date, 02/2016.

American Health Packaging initiated the voluntary product recall on July 1, 2014 as a safety precaution. Notification of the recall has been sent to distributors who received the affected product with instructions on how to notify their customers, the company reports in a statement.

This recall is being conducted with the knowledge of the FDA.

Source: FDA and American Health Packaging