Washington, DC: American Health Packaging (AHP) has voluntarily recalled Lot #142588, Expiration Date, 01/2016 of Ibuprofen Tablets, USP, 600 mg, in a hospital unit dose presentation that may contain individual blistered doses labeled as Oxcarbazepine Tablets, 300 mg, lot #142544. In addition, AHP has also voluntarily recalled Oxcarbazepine Tablets, 300 mg, lot #142544, Expiration Date, 02/2016.
This 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. Failure to receive the proper dose of oxcarbazepine could increase the chances of having a seizure. 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.
The recall affects:
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. The drug product can be identified by physical description: white, oval-shaped, film-coated tablets, with "IP 465"printed on one side.
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. The drug product can be identified by physical description: yellow color, capsule shaped, film-coated tablets scored and debossed with '184' on one side and scored on other side.
These hospital unit dose products were distributed nationwide beginning June 20, 2014.