Recalls

Mislabeled ibuprofen, seizure drugs recalled

American Health Packaging logo Mislabeled ibuprofen, seizure drugs recalledAmerican Health Packaging (AHP) is recalling packages of the anti-inflammatory drug ibuprofen and the anti-seizure drug oxcarbazepine because the individual blister packs may be mislabeled and contain the wrong drug. Thus, patients prescribed oxcarbazepine may inadvertently take a dose of ibuprofen, and patients prescribed ibuprofen may inadvertently receive oxcarbazepine. Patients who miss a scheduled dose of oxcarbazepine are at an increased risk of having a seizure. And, inadvertent consumption of ibuprofen may cause side effects in patients for which the medication is contraindicated.

The recall involves Lot #142588, Expiration Date, 01/2016 of ibuprofen tablets USP, 600 mg, in a hospital unit dose presentation, because they may contain individual blistered doses labeled as oxcarbazepine tablets, 300 mg, lot #14544. Additionally, the recall also involves oxcarbazepine tablets, 300 mg, lot #142544, Expiration Date, 02/2016. The hospital dose products were distributed nationwide beginning June 20, 2014.

The recall notice has been sent to distributors who received the affected drugs with instructions on how to notify their customers. Patients who have received these drugs should immediately discontinue use and contact GENCO Pharmaceutical Services at 855-419-4608 for instructions on returning the products.

Patients who experience side effects or have concerns after using these products should contact their doctors. Any adverse events should also be reported to the Food and Drug Administration MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.htm.

Source: FDA