American Health Recalls Ibuprofen, Oxcarbazepine due to Health Risk
American Health Packaging based in Columbus, Ohio has issued a recall of 600 mg Ibuprofen tablets and 300 mg of Oxcarbazepine tablets due to a serious risk to consumers. American Health Packaging issued this recall voluntarily, as reported by the U.S. Food and Drug Administration (FDA).
What is Ibuprofen and Oxcarbazepine?
The Ibuprofen 600 mg tablets are used to relieve mild to moderate pain. It is used for the relief of rheumatoid arthritis and osteoarthritis as well as the treatment of primary dysmenorrhea. The FDA website maintains that the “inadvertent consumption of ibuprofen may cause adverse reactions in a number of patients in which use of ibuprofen in contraindicated.”
Oxcarbazepine is mostly used for treating certain types of seizures in patients with epilepsy. If patients do not receive the proper dosage, it could increase the chances of having a seizure.
More About the American Health Recall
According to the FDA website, the Ibuprofen tablets are a hospital unit dose that may contain individual blistered doses labeled as Oxcarbazepine tablets 300 mg. The Oxcarbazepine tablets were also recalled because patients could be receiving ibuprofen and missing their scheduled dose of Oxcarbazepine due to a mislabeled inner unit dose blister packaging. There has been one customer complaint which has resulted in the immediate recall of the products. American Health Packaging reminds consumers who have received the recalled product to discontinue use immediately.
Description of the Recalled Ibuprofen, Oxcarbazepine
The FDA recall website lists the following information for each recalled product:
- Description of the American Health Ibuprofen:
- Cartons of 100 count (10×10) Hospital Unit Dose blisters of AHP Ibuprofen Tablets.
- They are 600 mg, with outer carton NDC#: 68084-703-01 and individual dose NDC#: 68084-703-11.
- The Lot number is 142588 and the expiration date is 01/2016.
- The product can be identified by the physical description of white, oval-shaped, film-coated tablets, with “IP 465” printed on one side.
- Description of the American Health Oxcarbazepine:
- Cartons of 100 count (10×10) Hospital Unit Dose blisters of AHP Oxcarbazepine Tablets.
- They are 300 mg, with an outer carton NDC#: 62584-143-0 and an individual dose NDC#: 62584-143-11.
- The Lot Number is 142544 with an expiration date of 02/2016.
- The product can be identified by the physical description of yellow color, capsule shaped, film-coated tablets. They are scored and debossed with “184” on one side and scored on the other.