June 15, 2017

 

 Phenobarbital bottles contain wrong tablets

Posted May 31, 2017

Bottles of phenobarbital contained tablets twice the strength listed on the label, leading to a recall starting in April.

The manufacturer expanded the recall in May to include four strengths of phenobarbital and one amitriptyline HCl product.

C.O. Truxton issued the recall April 21 for 1,000-count bottles labeled as containing 15 mg tablets but actually containing 30 mg tablets, according to a Food and Drug Administration announcement. Phenobarbital is used as a sedative or anticonvulsive.

On May 8, the FDA announced that the recall was expanded to include 30 mg, 60 mg, and 100 mg tablets of phenobarbital and 50 mg amitriptyline HCl tablets. The company had received no complaints about those products but issued the recall out of caution.

The recall affects 18 lots of tablets.

The following recalled 1,000-count bottles of 15 mg phenobarbital tablets have an NDC of 0463-6160-10: lot 70915A, expiring August 2017; H15A55 and 70952A, expiring November 2017; and 71162A, expiring October 2018.

The following recalled 1,000-count bottles of 30 mg phenobarbital tablets have an NDC of 0463-6145-10: lot 70926A, expiring November 2017; 70981A, expiring January 2018; and H15A59, expiring August 2018.

The following recalled 1,000-count bottles of 60 mg phenobarbital tablets have an NDC of 0463-6151-10: lot 70881A, expiring July 2017; H15A68, expiring January 2018; 70980A, expiring February 2018; and 71416A, expiring May 2020.

The following recalled 100-count bottles of 100 mg phenobarbital tablets have an NDC of 0463-6152-01: lot 70989A, expiring February 2018; and 70973A, expiring January 2018.

The recall affects two sets of 1,000-count bottles of 100 mg phenobarbital tablets. The following have an NDC of 0163-6152-10: lot 70973A, expiring January 2018; H15A76, expiring February 2018; and 71346A, expiring December 2019. The rest have an NDC of 0463-6152-01 and a lot number of 70989A, and they expire in February 2018.

And the recalled 100-count bottles of 50 mg amitriptyline tablets have an NDC of 0463-6352-10 and a lot number of C0260416A, and they expire in March 2018.

Truxton also is answering questions at 856-933-2333 from 9 a.m. to 5 p.m. EDT weekdays. The FDA provides information on filing adverse event reports connected with veterinary drugs here.