Mislabeling Causes Ibuprofen, Oxcarbazepine Recall
American Health Packaging announced a voluntary recall of Ibuprofen Tablets 600mg and Oxcarbazepine Tables 300mg due to mislabeled inner unit dose blister packaging. The mislabeling could result in patients receiving ibuprofen and missing their scheduled dose of oxcarbazepine.
Ibuprofen is indicated for the relief of mild to moderate pain; for relief of signs and symptoms of rheumatoid arthritis and osteoarthritis; and treatment of primary dysmenorrhea. Oxcarbazepine is indicated for the treatment of certain types of seizures in patients with epilepsy. If a patient does not receive the proper dose of oxcarbazepine, it could increase the chances of having a seizure.
The affected products are packaged in hospital unit doses and were distributed nationwide beginning June 20, 2014. The recall includes:
- Cartons of 100 count (10x10) Hospital Unit Dose blisters of AHP Ibuprofen Tablets 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 has notified distributors about the recall and provided instructions on how to notify their customers. Affected products should be returned to Genco Pharmaceutical Services by contacting (800) 707-4621.
For more information call (800) 707-4621 or visit the FDA Safety Alert page.