August 9, 2022

Ibuprofen and Oxcarbazepine Tablets Recalled for Incorrect Labeling

American health packaging is recalling Ibuprofen Tablet in a hospital unit dose presentation that may contain Oxcarbazepine Tablets. The recall is the result of a mislabeled inner unit dose blister packaging which could mean patients get ibuprofen instead of their scheduled dose of oxcarbazepine. There was one customer complaint that resulted in the investigation and recall. There have not been any adverse events reported to date. Oxcarbazepine is used for treating seizures in epilepsy patients.

Recall SignageThese are the affected products: Cartons of 100 count (10×10) 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.

And cartons of 100 count (10×10) 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. You can see pictures of the product labels at the FDA web site.

The hospital unit dose products were distributed nationwide beginning June 20, 2014. Any adverse reactions should be reported to the FDA’s MedWatch Program.

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