FDA labels ongoing Truxton phenobarbital and amitriptyline recalls as Class I, II

The FDA says ongoing Truxton recalls are Class I and Class II.

The FDA has classified the ongoing recall by drug wholesaler Truxton of 18 lots of phenobarbital and amitriptyline tablets as Class I and Class II recalls.

The voluntary recall was initiated by Truxton earlier this year due to issues with mislabeling of tablets of various dosages of phenobarbital and amitriptyline. The tablets were produced by West-Ward, which is owned by Jordan-based Hikma Pharmaceuticals. Truxton has said it hasn’t received any reports of adverse effects from the tablets that were distributed throughout the U.S. to physician and veterinarian treatment centers.

The recall classifications were recently posted on the agency’s website.

Phenobarbital is typically used as a sedative or anticonvulsant, while amitriptyline is used to help treat depression.