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April 2017

Is Your Dog Or Cat Taking Phenobarbital? C.O. Truxton, Inc. Issues Voluntary 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.

Original Recall - https://www.fda.gov/Safety/Recalls/ucm554329.htm

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Party Animal Cocolicious Beef And Turkey and Party Animal Cocolicious Chicken And Beef Recalled

Party Animal Statement on Cocolicious

April 17, 2017

Party Animal Cocolicious Beef And Turkey RecallThe safety of pets is and always will be our first priority. We sincerely regret the reports of the discomfort experienced by the pet who consumed this food. As pet parents ourselves, we take this matter seriously. On April 13, a retailer in Texas notified us that their customer had presented samples of our 13-ounce-can Cocolicious Beef & Turkey dog food (Lot #0136E15204 04, best by July 2019) and 13-ounce-can Cocolicious Chicken & Beef dog food (Lot #0134E15 237 13, best by August 2019) to a testing lab, and that the results had tested positive for pentobarbital. We have requested those results.

When we were notified, we immediately tracked the lot numbers of the food in question and determined that the food had been manufactured and distributed in 2015. We then contacted the two probable retailers that had sold the customer the food and asked them to isolate all remaining cans from these lots. If pet parents have cans with either of those lot numbers in their possession, they should return them to the place of purchase and will
of course receive a full refund.

We also requested that the retailers send all of the cans from those lots to us so that we can forward them on to an accredited independent laboratory for independent testing. We expect to receive the receive the results in 7 to 10 days. We first saw the formal report from the lab at Texas A&M regarding the customer’s samples, today, April 17.

Out of an abundance of caution, we are retrieving the remainder of these two lots nationwide. We are working with our distributors and retailers to determine if any additional beef-flavored products manufactured during this 2015 production period remain on shelves and, if so, to retrieve them from shelves, immediately, as well.

Party Animal wishes to emphasize that we have submitted many recent lots of our beef flavors for testing and all have tested negative for any pentobarbital. We have also had extensive discussions with our manufacturer regarding the potential cause of the reported contamination of the 2015 lots, and we will continue with such discussions even as we await testing results for the 2015 lots. In order to ensure adherence to our commitment to the safety of pets, we are also actively re-examining our manufacturing processes.

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