November 27, 2019
X-Gen Pharmaceuticals Inc. is recalling 25,120 vials of levetiracetam injection because they contain the wrong package insert, according to the November 27, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects levetiracetam injection, 500 mg/5 mL, 10 single-use 5-mL vials (NDC 39822-4000-1), from lots 7603333, 7603334, and 7603335 (Exp. 5/20) and 7051107 (Exp. 1/22). The product, manufactured for X-Gen Pharmaceuticals by Agile Specialties Private Limited, was distributed throughout the United States.
X-Gen Pharmaceuticals voluntarily initiated the recall October 11, 2019. The FDA designated the recall Class III on November 21, 2019. Under the recall classification, use of the affected medication is not likely to cause harm.
Levetiracetam is a prescription anticonvulsant used to treat seizures in adults and children with epilepsy.