Seizure Med Under Class I Recall

A Class I recall has been issued for a single lot of the anticonvulsant vigabatrin for oral solution because of a potential for powder to leak from product pouches and subsequent underdosing, according to the January 17, 2024, US Food and Drug Administration (FDA) Enforcement Report. The recall classification is the FDA’s strongest and warns use of the product could cause serious adverse health consequences or death.

“The population at risk is primarily infants and young children,” Cipla Limited and subsidiary InvaGen Pharmaceuticals Inc. announced in a December 15, 2023, statement. “In those patients, there is a reasonable probability that inaccurate dosing might result in a serious adverse effect such as intoxication or breakthrough seizures requiring medical intervention.”

The recall affects vigabatrin for oral solution, 500 mg per foil pouch (NDC 69097-964-53), in 50-pouch boxes, from lot NB301030 (Exp. 3/31/25). The product was manufactured by InvaGen Pharmaceuticals, Hauppauge, New York, for Cipla USA Inc., Warren, New Jersey, and was distributed throughout the United States. The recall includes 1240 boxes.

InvaGen Pharmaceuticals voluntarily initiated the recall November 17, 2023. The FDA issued its Class I designation on January 8, 2024. Vigabatrin for oral solution is a prescription medication used as adjunctive therapy for the treatment of refractory complex partial seizures in patients 2 years of age and older.