American Health Announces Voluntary Nationwide Recall of Ibuprofen Tablets and Oxcarbazepine

American Health Packaging (AHP) has voluntarily recalled of ibuprofen tablets, USP, 600 mg, in a hospital unit dose presentation that may contain individual blistered doses labeled as oxcarbazepine tablets, 300 mg.

In addition, the company has voluntarily recalled one lot of oxcarbazepine tablets, 300 mg. This voluntary recall is the result of mislabeled inner unit dose blister packaging, which could result in patients receiving ibuprofen and missing their scheduled dose of oxcarbazepine.

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. Inadvertent consumption of ibuprofen may cause adverse reactions in a number of patients in which use of ibuprofen is contraindicated.

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. 

To date, AHP has received one customer complaint, which resulted in the investigation and recall of these drug products. AHP has not received any adverse event reports attributable to the mislabeled drug.

AHP initiated a voluntary product recall as a safety precaution, and will continue to closely monitor for reports of adverse drug reactions and product complaints. Notification of the recall has been sent to distributors who received the affected product with instructions on how to notify their customers.