Monday, February 20, 2017

FDA Issues Report Findings on Dog Food Facilities With Pentobarbitol Issue

After an Indiana firm recalled canned dog for Pentobarbitol, a euthanizing agent, FDA completed and released inspections for the producing facility, Evangers of Wheeling IL and a related pet food facility run by same family, Nutripack of Markham IL.  FDA testing found Pentobarbitol in products from both facilities and both companies conducted recalls of lots of dog food made with beef from the same supplier (Evangers and Against the Grain).

FDA stated in their report "In its recent press release announcing a limited product recall, Evanger’s Dog & Cat Food Company, Inc. stated that the beef for its Hunk of Beef product came from a “USDA approved” supplier. However, the FDA reviewed a bill of lading from Evanger’s supplier of “Inedible Hand Deboned Beef - For Pet Food Use Only. Not Fit For Human Consumption" and determined that the supplier’s facility does not have a grant of inspection from the United States Department of Agriculture’s Food Safety and Inspection Service. The meat products from this supplier do not bear the USDA inspection mark and would not be considered human grade. USDA-FSIS regulates slaughter of animals for human consumption only. Testing by USDA-FSIS of Evanger’s Hunk of Beef confirmed that the meat used in the product was bovine (beef)."

FDA issued 483 (inspectional observations) reports for both facilities [included below],  Both reports point out numerous sanitary issues within both facilities. Nothing noted in the reports relates to the issue at hand, but does point out poor execution of sanitary operations.  The company tag line - People Food for Pets - not exactly.

In a letter posted on their internet site (posted below), the company blames their supplier.
In a quick internet search, I came by this gem with support.

FDA News Release
https://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm542265.htm
FDA Cautions Pet Owners and Caretakers Not to Feed Certain Evanger’s or Against the Grain Canned Pet Foods Due to Adulteration with Pentobarbital
February 17, 2017

The U.S. Food and Drug Administration is advising pet owners and caretakers not to feed their pets certain lots of Evanger’s canned Hunk of Beef or Against the Grain Grain Free Pulled Beef with Gravy canned dog food after unopened cans from both brands were found to contain pentobarbital, a barbiturate.

Pentobarbital is a drug that is used in animal euthanasia. It should not be in pet food and its presence as detected by the FDA in these products renders them adulterated.

The FDA was unable to determine from available records whether any other Evanger’s or Against the Grain products made with beef contain any of the beef that went into the recalled products. Additionally, the agency concluded an inspection of the manufacturing facilities on February 14, 2017, and noted numerous significant concerns with conditions found at both the Wheeling, IL and Markham, IL plants. These are initial observations and do not represent a final agency determination regarding the firm.

Following discussions with the FDA, Evanger’s initiated a voluntary recall on February 3, 2017, of certain lots of its 12-ounce Hunk of Beef canned dog food: 1816E03HB, 1816E04HB, 1816E06HB, 1816E07HB, and 1816E13HB, all with an expiration date of June 2020.

In the course of the investigation, the FDA tested two cans of Against the Grain brand canned Grain Free Pulled Beef with Gravy dog food manufactured in the same facilities as Evanger’s products and using beef from the same supplier: these samples also tested positive for pentobarbital. On February 9, 2017, after conversations with the FDA, Against the Grain voluntarily recalled lot 2415E01ATB12 BEST DEC 2019 of this product. The company issued a public notice about its recall on February 13, 2017. To date, the FDA is not aware of any pet illnesses associated with the Against the Grain product.

The FDA began investigating Evanger’s Dog & Cat Food Company Inc. when it learned about five dogs in a single household that suffered acute neurological symptoms shortly after eating the product. One dog was euthanized after secondary complications, and three others recovered after receiving veterinary care. One of the dogs treated remains on seizure medication, and the fifth dog that ate the least amount of food recovered with time.

The stomach contents of the deceased dog and an open can of the product were tested by an FDA Veterinary Laboratory Investigation and Response Network lab, and unopened cans of the product from the pet owner and retailer that sold the products (from the same production lot), were tested by FDA’s lab. All of the samples tested positive for pentobarbital.

In its recent press release announcing a limited product recall, Evanger’s Dog & Cat Food Company, Inc. stated that the beef for its Hunk of Beef product came from a “USDA approved” supplier. However, the FDA reviewed a bill of lading from Evanger’s supplier of “Inedible Hand Deboned Beef - For Pet Food Use Only. Not Fit For Human Consumption" and determined that the supplier’s facility does not have a grant of inspection from the United States Department of Agriculture’s Food Safety and Inspection Service. The meat products from this supplier do not bear the USDA inspection mark and would not be considered human grade. USDA-FSIS regulates slaughter of animals for human consumption only. Testing by USDA-FSIS of Evanger’s Hunk of Beef confirmed that the meat used in the product was bovine (beef).

The investigation by the FDA is ongoing and includes examination of the suppliers of beef to Evanger’s and Against the Grain to determine a possible cause for the presence of pentobarbital. The FDA is also coordinating with the USDA to address any possible areas of shared jurisdiction at the suppliers.

Oral exposure to pentobarbital can cause drowsiness, dizziness, excitement, loss of balance, nausea, nystagmus (eyes moving back and forth in a jerky manner), inability to stand, coma and death. Consumers who notice these symptoms in their pets should consult their veterinarian.

Consumers with cans of product subject to the facilities' voluntary recalls should refer to the firms’ respective press releases for information about returning the product.
Additional Information
How to Report a Pet Food Complaint
Company Press Release: Evanger’s Voluntarily Recalls Hunk of Beef Because Of Pentobarbital Exposure in one Batch of Food
Company Press Release: Against The Grain Pet Food Voluntarily Recalls One Lot of Pulled Beef Due to Potential Adulteration with Pentobarbital
FDA Form 483: Evanger’s Dog (PDF - 458KB)
FDA Form 483: Nutripack, LLC – Markham, IL (PDF - 575KB)
Veterinary Laboratory Investigation and Response Network (Vet-LIRN)


FDA 483 Reports
Evanger's Dog and Cat Food Company, lnc.
Wheeling, lllinois 60090
The following observations were found to be adulterated m1der the FederaJ Food, Drug, and Cosmetic Act:
A food shall be deemed to be adulterated if it bears or contains any added poi onous or added deleterious substance that is unsafe within the meaning of section 402. Specifically,
1.) Your low-acid canned dog food product labeled in part "EVANGER'S***HAND PACKED HUNK OF BEEF AUS JUS***NET WT 12 OZ***" and coded "1816E06HB13" was found by chemical analysis to contain the barbiturate drug pentobarbital.
2.) Your low-acid canned dog food product labeled in part "AGAINST the Grain***GRAIN FREE PULLED BEEF with Gravy***DINNER FOR DOGS***N T WT 12 OZ***" and coded "2415E01ATB12 BEST DEC 2019" was found by chemical analysis to contain the barbiturate drug pentobarbitol.
3.) On 01/10/2017 and 01 /l l/2017 condensate dripped throughout your processing facility from the building  framing, ceiling, walls, and from tarps suspended above food processing areas, including condensate dripping directly into open cans of the in-process low-acid canned dog food product HUNK OF BEEF, and also into multiple open totes of raw meats including beef intended for your canned dog food product HUNK OF BEEF.
4.) The floors throughout your processing facility are pitted, cracked, and otherwise damaged causing pooled  water in areas were food is exposed including where open cans of in-process HUNK OF BEEF dog food are staged on a wooden pallet immediately upon the damaged floor.
5.) Additional sanitary conditions observed on 01/10/2017 and 01/11/2017 include peeling paint and mold on the walls throughout the processing facility including in areas where food is exposed a live fly-like insect m the HUNK OF BE F hand-packing area during processing, and an open sanitary sewer within approximately 25 feet of two food storage trailers and one foodprocessi.ng trailer at the rear exterior of the facility.
6.) You lack operating refrigerated storage facilities or other means of controlling the temperature exposure of raw meats during thawing, storage and processing.
On 01/10/2017 and 01/11/2017 multiple approximate b) (4) of raw beef and other raw meats in various stages of thawing were stored at ambient temperature inside your processing facility and also at ambient temperature inside three trailers on the exterior grounds of your facility. The exterior ambient temperatures were below freezing on the e two inspection days. There was frozen ice containing a blood-Like substance across the floor of the three trailers and also on the gr und immediately outside of two of the trailer doors.
On O I/ 11/2017 hand packing operations started at approximately b) ( 4) for your HUNK OF BEEF canned dog food. Open can of beef were staged on a pallet at ambient temperature during the hand packing process. At the conclusion of the inspection at approximately 2:00 PM the hand packing operation was still in process with the fir t open cans of beef that were packed at approximate (b)(4)still staged at ambient temperature on with the bottom layer of the pallet of hand-packed cans.

Nutripack LLC
Markham, Illinois
The following observations were found to be adulterated under the Federal Food, Drug, and Cosmetic Act:
A food shall be deemed to be adulterated if it bears or contains any added poisonous or added deleterious substance that is unsafe within the meaning of section 402.
Specifically,
1.) Your low-acid canned dog food product labeled in part "AGAINST the Grain***GRAIN FREE PULLED BEEF with Gravy***DINNER FOR DOGS***NET WT 12 OZ***" and coded "2415E01ATB12 BEST DEC 2019" was found by chemical analysis to contain the barbiturate drug pentobarbitol.
*********************
A food shall be deemed to be adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Specifically,
2.) On 01/10/2017, 01/11/2017, 01/12/2017 and 01/31/2017 condensate dripped throughout your processing and storage facility from the building frame and ceiling.
•             Condensate dripping directly above open cans of the in-process low-acid canned dog food product COOKED CHICKEN LOAF and HAND PACKED CHICKEN.
•             Excessive pooling of condensation on pallets of stored product.
•             Excessive pooling of condensation on the floor of the shipping and receiving area.
3.) Frozen raw meats for processing are prepared while having direct contact with the insanitary, bare, paint peeling and unprotected concrete floor of the processing facility.
4.) On 01/31/2017 employees were observed cutting raw chicken parts on untreated wooden building construction lumber.
5.) Your storage facility was observed to have avian activity. Specifically, on dates 01/10/2017, 01/11/2017, 01/12/2017 and 01/31/2017;
•             Birds were observed feeding on spilled pet food foW1d in the expansion joints of the concrete floor.
•             Resting in rafters.
•             Flying through the warehouse.
6.) The floors throughout your processing facility are pitted, cracked, and otherwise damaged causing pooled water in areas were food is exposed including where open cans of in-process COOKED CHICKEN LOAF and HAND PACKED CHICKEN dog food are staged on a wooden pallet immediately upon the damaged floor.

https://www.fda.gov/Safety/Recalls/ucm541692.htm
Against The Grain Pet Food Voluntarily Recalls One Lot of Pulled Beef Due to Potential Adulteration with Pentobarbital
For Immediate Release
February 14, 2017
Contact
Consumers 708-566-4410
Media 708-566-4410

Announcement
View Product Photos

Out of an abundance of caution, Against the Grain Pet Food is voluntarily recalling one lot of Against the Grain Pulled Beef with Gravy Dinner for Dogs that was manufactured and distributed in 2015.

The 12 oz. Against the Grain Pulled Beef with Gravy Dinner for Dogs that is being voluntarily recalled, due to the potential presence of pentobarbital, has an expiration date of December 2019, a lot number of 2415E01ATB12, and the second half of the UPC code is 80001 (which can be found on the back of the product label).

Oral exposure to pentobarbital can cause side effects such as drowsiness, dizziness, excitement, loss of balance, nausea nystagmus (eyes moving back and forth in a jerky manner), inability to stand and coma.

Note: To-date, no complaints have been reported to Against the Grain for this single lot number nor any of Against the Grain’s pet foods, since the company was founded.

In 2015, this one lot of product was distributed to independent pet retail stores in Washington and Maryland, though it has been verified that this lot is no longer on any store shelves. This voluntary recall only affects one specific lot of food.

Consumers may return any can with the aforementioned lot number, to their place of purchase and receive a full case of Against the Grain food for the inconvenience. For any questions, customers may contact the company at 708-566-4410 between 11:00 AM – 4:00 PM Central Time, Monday - Friday.
FDA Cautions Pet Owners and Caretakers Not to Feed Certain Evanger’s or Against the Grain Canned Pet Foods Due to Adulteration with Pentobarbital


Evanger's Website
https://evangersdogfood.com/news-events/pug-family-updates/

UPDATE 2-19-2017

“Even One Recall in 82 Years is One Too Many!”

Dear Pet Parents:

You’ve undoubtedly heard about the many voluntary pet food recalls that have occurred during this past week from many companies, as well as from our company. You may have even purchased some of the recalled foods yourself in your desire to feed your 4-legged children only the healthiest, safest, and most nutritious food possible.

We are very aware that these recalls have rightfully caused a great deal of justified concern, mistrust, and anger among both pet owners and pet food retailers alike.

The Evanger’s family, like many families, is, also, incredibly angry and upset by the recalls of the past week. However, it’s not for the reason you may think.

We’re angry because we let you and your pets down.

Whether you’re one of the hundreds of thousands of loyal customers who have trusted us for over 82 years to make only the safest, most palatable, and nutritious dog food that you can buy; or if you’re one of the thousands of retailers who proudly sell our products to customers whose trust and loyalty you work so hard to earn 7 days a week – we let all of you down.

In early January, we were profoundly saddened when we learned, through a posting on social media, that 5 dogs from the same household became ill and one of them later was put down after eating our Hunk of Beef canned dog food. Our initial response was to conduct all appropriate testing for pathogens and processing, all of which came up negative. After a plethora of specialized tests, it was determined that the meat in Hunk of Beef dog food, of which the dogs shared a can, contained pentobarbital, which is the drug that veterinarians use to euthanize companion animals and horses, and an anti-seizure and insomnia medication for humans. Because “Hunk of Beef” contains only 1 ingredient, 100 percent Beef Roast, we immediately suspected that the pentobarbital had somehow gotten into the meat supply, unbeknownst to us.

Although we hadn’t heard of any other instances of dogs getting sick, we took it upon ourselves to immediately issue a voluntary recall of 60,000 cans of Hunk of Beef that were produced at the same time as the can containing the pentobarbital was made. A report of 1 dog getting sick is 1 dog too many.

Our investigation continued after issuing the recall. We had to determine how and why pentobarbital made its way into the meat that is used in our top selling product; a product that is intended to actually enhance the wellbeing and quality of life of our companion animals through its unique minimally processed hand packing process.

The guilty party has turned out to be one of our most trusted meat suppliers. A USDA-APHIS inspected supplier who we had done business with for over 40 years, and whose plant we had visited numerous times over the years.

We found that although cows can be euthanized, it is not common practice, so we sent a can of the recalled product to a lab for genetic species identification. We purchased hand deboned beef from this previously trusted supplier, but we suspect that the results will put the missing pieces of the puzzles together, and may confirm how pentobarbital entered the supplier’s meats.

Needless to say, we immediately ceased relations with that supplier and have undertaken legal steps to address this matter on behalf of our customers and retailers.

We will continue to keep you updated as to the status of our recall, as we have been doing, and pending litigation.

Most importantly, we will continue to work hard every day to re-earn your trust. We have taken it upon ourselves to lead the campaign to force the FDA to put an end to allowing drugs like pentobarbital to enter the raw material stream and contaminate our pets’ food and endanger their lives.

Sincerely,

The Sher Family, Proud Owners of Evanger’s Dog Food


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