DRUG RECALLS

winter care and travel tips for dogs who may be exposed to hypothermia and frostbite. hypothermia and frostbite symptoms are easily detected.
doghouses should have a southern exposure, doghouses must have an entrance that is properly sized the doghouse should have a platform and
insulated floor, properly sized entrances and platform with an insulated floor give better protection and warmth for the dog. when traveling with your
dog keep in mind the most important things with traveling with a dog does have prerequisites.
Bellmawr, New Jersey, C.O. Truxton, Inc. is expanding their – 04/21/2017 voluntary recall, as a
precaution to include the following C.O. Truxton, Inc. products, registered NDC numbers and
corresponding lot numbers, to the consumer/user level. C.O. Truxton has not received any
complaints for the products listed below – however, due to the initial recall resulting from a
label mix-up error, out of an abundance of caution, we are recalling all products that were
repackaged into a Truxton Incorporated label.
Product Name NDC Code  Lot Number Expiration
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

If mislabeled, inadvertent exposure to, or overdose of phenobarbital could cause severe
intoxication which may lead to cardiogenic shock, renal failure, coma, or death in humans and
If mislabeled, inadvertent exposure to, or overdose of amitriptyline could cause uneven
heartbeats, extreme drowsiness, confusion, agitation, vomiting, hallucinations, hot or cold
sensations, muscle stiffness, seizures (convulsions), or fainting in humans and animals. C.O.
Truxton, Inc. has not received any reports of adverse events related to this recall.

Phenobarbital is indicated for use as a sedative or anticonvulsant and is packaged in the
following configurations:

NDC   Package Size   Strength (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 indicated for use as a tricyclic antidepressant and is packaged in the following

NDC   Package Size  Strength (mg)  Tablet Appearance Side One Tablet  Side Two
0463-6352-10 100 50 2103, beige V, beige

The product was distributed nationwide in the U.S.A. to physician & veterinarian treatment
C.O. Truxton, Inc. is notifying all customers on record who purchased the above listed
products under Truxton Incorporated label/NDC via US Mail with a recall letter and recall
response form.  C.O. Truxton, Inc. and is arranging for full credit returns, replacements, etc. of
all recalled product. Consumers/distributors/retailers that have recalled product should stop
using the product immediately and return their product to the place of purchase.

Consumers with questions regarding this recall can contact C.O Truxton, Inc. by phone at
(800) 257-7704, Monday to Friday between the hours of 9am and 5pm (EST). Consumers
should contact their physician, healthcare provider, or veterinarian if they have experienced
any problems that may be related to taking or administering these drug products.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration