Nationwide Recall of Phenobarbital 15 mg Tablets, USP due to Labeling Error on Declared Strength

For Immediate Release

April 21, 2017

Contact

Consumers

Paul F. Devine
 (856) 933-2333

Announcement

Bellmawr, New Jersey, C.O. Truxton, Inc. is voluntarily recalling lot 70952A of Phenobarbital Tablets, USP, 15 mg, to the consumer/user level. The manufacturer received a confirmed customer complaint that a bottle labeled as phenobarbital 15 mg was found to contain phenobarbital 30 mg tablets.

This mislabeled product could expose the consumer or their pet(s) to potential overdosing that can cause severe intoxication which may lead to cardiogenic shock, renal failure, coma or death. C.O. Truxton, Inc. has not received any reports of adverse events related to this recall.

The product is indicated for use as a sedative or anticonvulsant and is packaged in 1000 count bottles, NDC 0463-6160-10, UPC 7 0463616010 6, lot number 70952A, expiration date 11/17. The 15 mg Tablet is debossed with “West-ward 445” on one side and blank on the reverse side; the 30 mg Tablet is debossed with “West-ward 450” on one side and scored on the reverse side. The product was distributed Nationwide in the USA to Physician & Veterinarian Treatment Centers.

C.O. Truxton, Inc. is notifying all customers on record who purchased the affected product via US Mail which includes a recall letter, recall response form 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 and return their product to their place of purchase.

Consumers with questions regarding this recall can contact C.O Truxton, Inc. by phone at (856) 933-2333, Monday to Friday between the hours of 9am and 5pm (EST).  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail or by fax.

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

Company Contact:

C.O. Truxton, Inc.
Mr. Paul F. Devine
(856) 933-2333

 

SOURCE C.O. Truxton, Inc.

Related Links

http://www.truxtonpharma.com

###

The original recall can be found here.

Source: FDA

Follow FDA

Follow @US_FDA on Twitter
Follow FDA on Facebook
Follow @FDArecalls on Twitter
Recent Recalled Product Photos on FDA’s Flickr Photostream


See other Pet Food Recalls
Read more articles in the category Health and Welfare and see other Press Releases

Browse some rescued cats and kittens!

FinnBaxter-ad


Art and Gifts featuring cats you know! Visit Portraits of Animals

AfterDinnerNap-Etsy

~~~

Handmade Gifts from Portraits of Animals!

After Dinner Nap keepsake

After Dinner Nap 10″ Rectangular Keepsake Box: This box has my painting “After Dinner Nap” on the top and a green and copper crackle finish on the sides. Box measures 10″ x 8″ x  4.5″ high. “The face that launched a thousand portraits,” my Stanley, the feline mascot of my business, appearing on my business card and brochure cover. You can find this keepsake box in my gallery of Handmade Gifts.


All images and text used on this site are copyrighted to Bernadette E. Kazmarski unless otherwise noted and may not be used without my written permission, although links to your site are more than welcome and are shared. Please ask if you are interested in using and image or story in a print or internet publication. If you are interested in purchasing a print of an image or a product including it, check my animal and nature website Portraits of Animals to see if I have it available already. If you don’t find it there, visit Ordering Custom Artwork for more information on a custom greeting card, print or other item.


© 2017 | www.TheCreativeCat.net | Published by Bernadette E. Kazmarski
Weekly schedule of features:
Sunday: Essays, Pet Loss, Poetry, The Artist’s Life
Monday: Adoptable Cats, TNR & Shelters
Tuesday: Rescue Stories
Wednesday: Commissioned Portrait or Featured Artwork
Thursday: New Merchandise
Friday: Book Review, Health and Welfare, Advocacy
Saturday: Your Backyard Wildlife Habitat, Living Green With Pets, Creating With Cats
And sometimes, I just throw my hands in the air and have fun!

PORTRAITS OF ANIMALS WEBSITE
FACEBOOK | TWITTER | LINKEDIN | PINTEREST | TUMBLR | INSTAGRAM | YOUTUBE | GOOGLE+ | EMAIL

HOME

Related Posts Plugin for WordPress, Blogger...

Bernadette

From health and welfare to rescue and adoption stories, advocacy and art, The Creative Cat offers both visual and verbal education and entertainment about cats for people who love cats. From catchy and creative headlines to factual articles and fictional stories, The Creative Cat provides constant entertainment and important information to people who love cats, pets and animals of all species.

Leave a Reply

Follow

Get every new post delivered to your Inbox

Join other followers