According to the U.S. Food and Drug Administration
(FDA), the tablets have voluntarily been recalled due to labeling error. The 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. Oxcarbazepine
is used for treating certain types of seizures in patients with epilepsy.
In contrast, Ibuprofen
is a non-steroidal anti-inflammatory drug used for relieving pain, helping with fever and reducing inflammation.
This is important because 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
The affected lot, produced by American Health Packaging
, is #142588, with an expiration Date, 01/2016. This lot may contain Oxcarbazepine tablets, 300 mg, lot #142544. These hospital unit dose products were distributed throughout the U.S. beginning June 20, 2014.
FDA recommends that consumers who have received the recalled product should discontinue use and contact GENCO Pharmaceutical Services at 855-419-4608 from 7am to 5pm CST for instructions on returning the recalled product.