September 27, 2019
West-Ward Columbus Inc. is recalling 32,347 bottles of oxcarbazepine oral suspension because the drug failed to meet impurity/degradation specifications, according to the September 25, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects oxcarbazepine oral suspension, 300 mg/5 mL, 250 mL per bottle (NDC 0054-0199-59), from lots AA3957A (Exp. 5/20), AA3958A (Exp. 5/20), and AA5164A (Exp. 9/20). The lots were distributed by West-Ward Pharmaceuticals throughout the United States and Puerto Rico.
The voluntary recall was initiated by West-Ward Columbus on September 9, 2019. On September 16, 2019, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Oxcarbazepine oral suspension is a prescription medication used to treat people with epilepsy.