August 22, 2019
American Health Packaging is recalling a single lot of carbamazepine tablets because samples failed to meet dissolution specifications during routine testing. The recall was announced in the August 21, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 10-dose blister packs, sold in cartons of 30 tablets, of extended-release carbamazepine, 400 mg (unit dose NDC 68084-562-11; carton NDC 68084-562-21). The recalled tablets were from lot 181677 (Exp. 11/30/20), which was distributed throughout the United States.
American Health Packaging voluntarily initiated the recall August 9, 2019. On August 15, 2019, the FDA designated the recall Class II. Under Class II recalls, use of the product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
Carbamazepine is a prescription anticonvulsant used to treat people with seizures, nerve pain, or bipolar disorder.