Evanger’s pentobarbital recalls. A peek behind the curtain.

On February 3, 2017, Evanger’s Dog & Cat Food Co. announced a recall of specific production lots of its Hunk of Beef au Jus canned dog food after pentobarbital was confirmed in samples of the product.

One month later, the company expanded its recall to include every batch of Hunk of Beef, Braised Beef and Against the Grain Pulled Beef canned dog foods manufactured between December 2015 and January 2017.

FDA categorized the recalls as Class I.

A Class I recall represents “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

More than two years later, these Class I recalls are still listed as “Ongoing” by FDA.

A series of email exchanges between Evanger’s, its attorneys, its consultants and FDA staff, released in response to a Freedom of Information Act request, offer a glimpse into the prickly relationship between Evanger’s and FDA.

The story began on December 31, 2016 when Nikki Mael gave her five dogs a New Year’s Eve ‘treat’, consisting of most of the contents of a can of Evanger’s Hunk of Beef au Jus dog food. Within 15 minutes, the dogs began to behave oddly, exhibiting acute neurological symptoms. The pet owner rushed her dogs to an emergency veterinary clinic, where one of the dogs died.

Lab tests conducted on stomach contents retrieved during necropsy of the dead dog revealed the presence of a large amount of pentobarbital, a drug used to euthanize animals. The same drug was found in the residue of food remaining in the can from which the five dogs were fed.

FDA, alerted by the veterinarian, launched its investigation into the incident, including an inspection of Evanger’s production facilities that began on January 10, 2017.

According to a February 4th email from Evanger’s to FDA, the agency first advised Evanger’s of the results of the necropsy on January 27th.

Evanger’s management protested FDA’s handling of the incident. In a series of emails, the company questioned FDA’s determination that pentobarbital was an adulterant, and cautioned the agency not to put too much credence in consumer complaints.

The company’s outside consultant had this to say in an email addressed to Joel Sher, Vice-President of Evanger’s, dated February 4, 2017.

I am dismayed by CVM’s determination. Low levels of Pentobarbital have positive uses in treating seizures and insomnia, both in humans and animals. Those who made the decision are obviously unaware of FDA’s 1998 study that found Pentobarbital in almost 50% of the dry dog foods tested and made a determination at that time that residues of Pentobarbital were acceptable.

Evanger’s consultant made reference to a 1986 fraudulent complaint targeting Gerber’s baby food before summarized the company’s thoughts regarding consumer complaints in the following words, taken from an email dated February 17, 2017.

Complaints cannot be trusted! Once a complaint hits the press unscrupulous people will line up complaining hoping for a payout. Back in 1986 FDA did not have the Office of Criminal Investigations to conduct follow-ups at complainants to interrogate them to determine if their complaints were legitimate or not. Today FDA does have that ability and, perhaps, some of the complaints against Evanger’s and Against the Grain should be investigated further by FDA. I would really caution FDA about coming out with a press statement about receiving ‘many’ complaints against these products unless a comprehensive analysis of the complaint is done first.

In a March 3rd email, Evanger’s attorney expressed concern about FDA’s press releases, and asked the agency to give Evanger’s the opportunity to ‘address the issues’ prior to issuing a new public alert, as follows:

Please recall I represent Evanger’s. On its behalf, I’d like to request that the FDA communicate to and work with Evanger’s after the completion of any investigation or the discovery of any new information or questions so that, prior to any new press release from the FDA, Evanger’s is given the opportunity to address the issues. As I am sure you are aware, an FDA press release has significant impact in the market; this is obviously the FDA’s intended effect with the goal of protecting the public. This is indeed the goal the FDA and Evanger’s share.

Later in the same email, the attorney wrote,

It is for this reason that we ask that, Evanger’s be given the opportunity to address new questions, issues or concerns before the FDA issues an independent release. If this is not possible, I believe Evanger’s would be entitled to know why so as to preclude even the appearance of arbitrary or capricious action.

On June 29, 2017, FDA issued a formal Warning Letter to Evanger’s, listing the various violations of the Federal Food, Drug & Cosmetics Act documented during the agency’s January inspection of the company’s facilities.

On July 9, 2017, a “concerned consumer” sent the following email to FDA.

Dear Mr. Lyons,

I am responding, to the letter that your office sent to Evanger’s Dog And Cat Food Company, dated June 29, 2019. The reason is the FDA has made false Allegations against Evanger’s in the following way: [redacted by FDA].

The anti seizure medication contained 30 mg of phenobarbital not 15 mg. The medication has since been recalled by a company called Truxton because of mislabeling. [redacted by FDA]

Again the FDA jumped the gun when Evanger’s got blamed for the dogs deaths.

[redacted by FDA]

5. The FDA came charging in like a bull, and the FDA failed to ask about the medical history of the dogs. The phenobarbital that you found came from a labor dispute between the meat supplier and its employee.

Before you make any more false and misleading information about Evanger’s, you need to check your facts. As you have caused thousands of dogs to lose a perfectly safe free meal. Please correct your letter and investigate the new facts in this case. Thank you [redacted by FDA]

Ps. Let me also make it clear I am just a concerned consumer writing this letter by myself.

In October 2017, the company and FDA were still in correspondence regarding the destruction of the recalled products. An October 18, 2017 email from FDA to Evanger’s attorney provides a window into some of the ongoing issues.

As you may know, FDA initiated an inspection at the Evanger’s Markham, IL facility on Tuesday, October 10, 2017 (and is still currently in progress). According to our investigators, the firm has approximately only [redacted by FDA] pallets of recalled product in their possession at this location. The amount of recalled product originally inventoried at the firm in February 2017 by FDA was approximately [redacted by FDA] pallets of product. The firm stated they are destroying the product by discarding approximately [redacted by FDA] at a time into their regular trash bin and covering the product in trash; the trash is then collected per their regularly scheduled pickup. The firm has not provided any documentation or evidence that the product was destroyed; however, Chelsea Sher stated on the second day of the inspection that some of the product has been disposed of at a landfill with documentation. Documentation of the landfill destruction has not been provided to the investigators either. According the investigators the firm is also not rendering the product unsalvageable when the product is thrown into the trash.

Relations between FDA and the companies it regulates can be difficult. Fortunately, not every recall situation is fraught with the controversy and confrontation that characterized the interaction between Evanger’s and FDA.

A final note: All of the excerpts quoted above are ‘as written’ except for the indicated redactions by FDA. No attempt was made to abridge the content or correct any errors of fact, spelling or grammar.

Multistate E. coli O26 outbreak linked to flour

Flour manufactured by ADM Milling and sold by Aldi has been linked to 17 cases of E. coli O26 illness in eight states.

Three people have been hospitalized.

ADM Milling and Aldi have jointly recalled all lots and date codes of the following product:

Bakers Corner All Purpose Flour (5-lb bag; UPC 041498130404)

The recalled product was sold in Connecticut, Delaware, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Vermont and West Virginia.

According to CDC, illnesses associated with this outbreak have been reported in California (1), Connecticut (1), Missouri (1), New Jersey (1), New York (5), Ohio (5), Pennsylvania (2), and Rhode Island (1).

Illnesses started on dates ranging from December 11, 2018 to April 18, 2019. Ill people range in age from 7 to 86 years, with a median age of 23. Sixty-five percent of the outbreak victims are female.

DNA analysis of an E. coli O26 recovered from an unopened bag of flour revealed a close genetic relationship to the outbreak strain, according to FDA.

Individuals infected with E. coli O26 may experience symptoms that include severe stomach cramps, diarrhea, fever, nausea, and/or vomiting. Some infections can cause severe bloody diarrhea and lead to life-threatening conditions, such as a type of kidney failure called hemolytic uremic syndrome (HUS), or the development of high blood pressure, chronic kidney disease, and neurologic problems.

Symptoms may not develop until as long as nine days follwoing infection.

Anyone experiencing symptoms of E. coli O26 infection should consult a healthcare provider.

FDA offers the following recommendations to consumers and food handlers:

DO NOT use or eat flour from five-pound bags of Baker’s Corner All Purpose Flour packed for ALDI, that includes all lot codes and all Best If Used By Dates distributed in Connecticut, Delaware, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Vermont and West Virginia.
DO NOT eat any raw cake mix, batter, or any other raw dough or batter product that is supposed to be cooked or baked.
WASH hands, work surfaces, and utensils thoroughly after contact with flour and raw batter or dough products.
KEEP raw foods separate from other foods while preparing them to prevent any contamination that may be present from spreading. Be aware that flour or cake mix may spread easily due to its powdery nature.

Caito Foods sanitation problems extend back to at least 2016

The following story by Phyllis Entis first appeared in Food Safety News and is reposted here with permission

The Food and Drug Administration found multiple sanitation issues during a 2016 inspection of the Caito Foods fresh produce facility that prepared pre-cut melon products currently implicated in a Salmonella outbreak.

According to the Indianapolis company’s website, Caito specializes in fresh produce distribution and fresh food processing, selling to customers nationwide.

The September 2016 FDA inspection was undertaken following detection of Listeria monocytogenes in a sample of cut butternut squash by the Ohio Department of Agriculture (ODA), according to documents obtained from FDA in response to a Freedom of Information Act request.

The company decided not to recall the squash from the sampled lot, because the product was intended to be cooked by the consumer. Also, the company did not learn about the contamination until Sept. 9, 2016, which was five days after the “BEST IF SOLD BY” date for the batch.

FDA investigators spent two days on a “directed inspection” in response to the Listeria monocytogenes finding. Their inspection focussed on the processing of raw fruits and vegetables, including butternut squash.

The “Establishment Inspection Report” noted several observations, which were provided to management at the completion of the inspection.

Condensate dripping onto uncovered asparagus spears on the over-wrap line during the, even though the pre-operation sanitation checklist indicated “No condensation” for that date.
Pre-operation sanitation check list for the date during which the butternut squash sample was produced identified three locations as “unsatisfactory” with no corrective actions indicated.
During the inspection, an employee on the production line was observed placing “. . . waste into a trash can under the product line, pushing the waste down into the can with their hand, until their arm from the elbow down was fully in the trash can.” The employee immediately returned to handling cut watermelon chunks without changing or sanitizing gloves.
Condensate water formed a puddle on the floor at one of the entrances to the receiving cooler, a potential reservoir for Listeria, which could be tracked into the rest of the facility.

Caito’s production facility was inspected again by FDA in 2018, in response to an outbreak of Salmonella Adelaide infections linked to freshcut melon products. That outbreak sickened 77 individuals in nine states.

On April 12 this year, Caito recalled various pre-cut melons and fruit medley products after the products were linked to cases of salmonellosis. As of April 24, there were 117 confirmed patients in the 10-state outbreak. At least 32 of the patients have been admitted to hospitals, according to an update this week from the Centers for Disease Control and Prevention.

The FDA is conducting an on-going investigation to determine the cause of the outbreak, including a traceback investigation to determine, if possible, a farm of origin for the melons. According to an agency spokesperson, FDA’s inspection of Caito’s production plant is still in progress.