RECALL: Phenobarbital and Amitriptyline Recall Expanded
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.
