RECALL: Phenobarbital and Amitriptyline Recall Expanded

May 9, 2017
American Veterinarian Editorial Staff

Following an initial recall of one lot of phenobarbital tablets resulting from a label mix-up error, Truxton Inc. is expanding its voluntary recall to include more lots of phenobarbital and amitriptyline tablets.

Truxton Inc., a medical supply store in Bellmawr, New Jersey, is issuing a nationwide voluntary recall of both amitriptyline and phenobarbital tablets due to a potential label mix-up.

Phenobarbital is an anticonvulsant commonly used to treat epilepsy in dogs and cats. Amitriptyline, a tricyclic antidepressant, is used to control behavior problems in pets, including separation anxiety, noises phobias, and anxiety in dogs and urinating out of the litter box, spraying, and anxiety in cats.

On April 21, the company recalled 1 lot of its phenobarbital 15-mg tablets due to the bottle actually containing 30-mg tablets. Now, the company is expanding this recall to include several other products.

Product Name NDC CodeLot NumberExpiration

Phenobarbital Tablets, USP 15mg (1000)

0463-6160-10

70915A

August 2017

H15A55

November 2017

70952A

November 2017

71162A

October 2018

Phenobarbital Tablets, USP 30mg (1000)

0463-6145-10

70926A

November 2017

70981A

January 2018

H15A59

August 2018

Phenobarbital Tablets, USP 60mg (1000)

0463-6151-10

70881A

July 2017

H15A68

January 2018

70980A

February 2018

71416A

May 2020

Phenobarbital Tablets, USP 100mg (100)

0463-6152-01

70989A

February 2018

70973A

January 2018

Phenobarbital Tablets, USP 100mg (1000)

0163-6152-10

70973A

January 2018

H15A76

February 2018

71346A

December 2019

Phenobarbital Tablets, USP 100mg (1000)

0463-6152-01

70989A

February 2018

Amitriptyline Tablets, USP 50mg (100)

0463-6352-10

C0260416A

March 2018

An overdose of phenobarbital could cause severe intoxication, which could lead to cardiogenic shock, renal failure, coma, or death in both humans and animals. An overdose of amitriptyline could cause uneven heartbeats, extreme drowsiness, confusion, agitation, vomiting, hallucinations, hot or cold sensations, muscle stiffness, seizures, or fainting in both humans and animals.

Phenobarbital is packaged in the following forms:NDC Package SizeStrength (mg)Tablet Appearance Side OneTablet Appearance Side Two

0463-6160-10

1000

15

West-ward 445, white

Blank, white

0463-6145-10

1000

30

West-ward 450, white

Score line, white

0463-6151-10

1000

60

WW 455, white

Blank, white

0463-6152-01

100

100

WW 458, white

Score line, white

0463-6152-10

1000

100

WW 458, white

Score line, white

Amitriptyline is packaged in the following form:NDC Package SizeStrength (mg)Tablet Appearance Side OneTablet Appearance Side Two

0463-6352-10

100

50

2103, beige

V, beige

Truxton has not received any complaints for any of the recalled products to date. The company is arranging for full credit returns and replacements for all recalled products purchased. If you have purchased 1 of the recalled products, discontinue use immediately and return the product to the place of purchase.

For more information, call Truxton at (800) 257-7704.