Recalls and Alerts: August 6 – 8, 2018

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

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United States

Allergy Alert: Mojave Foods Corporation recalls El Guapo Jamaica Hibiscus Flower (1-, 2-, 8-, & 16-oz packages; various Best before dates) due to undeclared peanut. Please refer to the recall notice for a complete list of affected products, which were shipped to Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Oregon, New Mexico, Nevada, Tennessee, Texas, and Utah.

Allergy Alert: JR Simplot Company Food Group recalls Simplot Good Grains Exotic Grains and Fire-Roasted Vegetable blend (Lot Codes 389 MAY 04 18 & 389 JUL 10 18) due to undeclared wheat.

Misbranding: StoneRidge Wholesale Division LLC recalls approximately 656 pounds of fully cooked, not shelf stable ready to eat pork and beef bologna products due to undeclared sodium nitrite and sodium erythorbate. Please refer to the recall notice for complete details on the affected products.

Pet Food Safety Recall: G & C Raw, LLC recalls Pat’s Cat Turkey Cat Food (1-lb pkgs; Lot #WWPKTF051618) and Ground Lamb Dog Food (2-lb packages; Lot #MFF022718) due to Listeria monocytogenes contamination. The recalled products were distributed by direct deliver to customers in OH, MI, IN, PAN, KY, NC, AND GA.

OTC Pharmaceutical Safety Recall: Product Quest Manufacturing LLC recalls CVS Health 12 Hour Sinus Relief Nasal Mist (0.5 fluid ounce bottle; Lot #173089J; EXP 09/19; UPC 50428432365) due to Pseudomonas aeruginosa contamination.

Canada

Food Safety Recall: Dole Fresh Vegetables Inc. recalls Dole brand Baby Spinach with Tender Reds (142g; Best Before 18-AU-04, All time codes starting with W202011; UPC 0 71430 06069 8) due to Listeria monocytogenes contamination.

Europe

Allergy Alert (Sweden): Axfood recalls Garant Salta chips (200g; Best before 18.01.2019; time stamp between 06:06 and 08:08) due to undeclared milk protein.

Allergy Alert (UK): Star Distribution (UK) Ltd recalls Cake Zone Muffins 4 pack Chunky Cherry and Double Chocolate Flavour (18x18x7cm pkg; Batch code 54–68060618; Best before 31 August 2018) due to undeclared egg, milk and wheat (gluten).

Food Safety Recall (Belgium): PLUIMVEESLACHTERIJ LAMMENS recalls Carrefour brand MB AILES DE POULET CURCUMA (550g; Best before 09/08/2018; LOT #6795) due to possible Salmonella contamination.

Food Safety Recall (Denmark): NatureSource recalls Clearspring Organic buckwheat flour (375g; Best before 25/10/2019) due to elevated ochratoxin levels.

Food Safety Recall (Germany): Penny Markt GmbH, Lidl, Kaufland, Aldi Süd, Real SB Warenhaus GmbH recall Organic Shell Eggs (10-pack and 6-pack; Lot #0-DE-0359721; Best before until 24.08.2018) due to Salmonella contamination.

Food Safety Recall (Sweden): Orkla Foods recalls Paulúns Superbars (all best-before dates until 24.04.2019) due to foreign matter (glass) contamination.

Australia and New Zealand

Allergy Alert (Australia): Rafferty’s Garden recalls Rafferty’s Garden Baby Rice Cereal (80g; Best Before 17 May 2019) due to undeclared gluten (oats).

Allergy Alert (New Zealand): Rosa Foods Ltd recalls The Wrappery brand Thai wrap (275g; Use by 19 August 2018 ) due to undeclared peanuts, sesame and fish.

Food Safety Recall (Australia): Home Ice Cream Pty Ltd recalls Gary Gumball 6 Pack Box and Impulse Individual Serve (various Best before dates) due to foreign matter (glass) contaminaion. Please refer to the recall notice for a complete list of affected products.

Darwin’s QA program evolves in response to FDA enforcement measures

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

Arrow Reliance Inc., dba Darwin’s Natural Pet Products, is taking steps to correct multiple violations of the Federal Food, Drug, and Cosmetic Act discovered during an investigation of Darwin’s raw pet food manufacturing facility in December 2017 and January 2018.

The Food and Drug Administration detailed the problems in a warning letter April 2.

A redacted copy of Darwin’s response letter was obtained by Food Safety News in response to a Freedom of Information Act request.

The investigation was triggered by a series of product recalls announced by the company in late 2017 due to Salmonella contamination in samples of Darwin’s raw frozen pet foods, following customers’ complaints of a kitten death and other ill pets. The joint investigation was carried out by the FDA and the Washington State Department of Agriculture (WSDA).

The FDA warning letter, and the Establishment Inspection Report that preceded it, highlighted several issues, including:

Bacterial pathogens (Salmonella, Listeria monocytogenes and/or E. coli O128) present in samples of various Darwin’s Natural Selections and ZooLogics brands of raw pet food;
The identical strain of Salmonella was recovered from both the dead kitten and a sample of food that had been fed to the kitten;
The protocol used by Darwin to reduce pathogen contamination through the application of bacteriophages had not been validated;
Failure to conduct operations under cGMPs (current Good Manufacturing Practices)
Raw materials not thawed under conditions that would minimize potential for growth of undesirable pathogens;
Animal food contact surfaces not made of appropriate materials or maintained to protect animal food from becoming contaminated; and
Equipment and utensils not used appropriately to avoid adulteration of animal food with contaminants.

In its response to the FDA warning letter, Darwin officials reported conducting a risk assessment to identify the root cause or causes of contamination. Based on the results of their assessment, the company concluded that the primary source of their contamination problem was pathogens present in some raw materials.

To address that issue, Darwin has adopted new approaches to reducing or eliminating pathogens in those raw materials, including:

Requiring all meat suppliers and produce suppliers to use a pathogen-reducing treatment (details redacted) prior to shipping raw materials;
On-site audits of meat suppliers and primary produce supplier;
Pathogen testing conducted by an independent testing lab of a number of inbound raw materials;
Additional “interventions” that are being evaluated (details redacted) for possible inclusion in the company’s processes to further reduce pathogen levels;
Increasing the dosage of bacteriophages to match the manufacturer’s “standard” recommended dosage and tested a revised method of application; and
Conducting validation tests, which were carried out by an independent testing lab, to confirm the effectiveness of the higher bacteriophage dosage and revised application method.

According to Darwin’s response letter, in 2016, the company hired a Quality Assurance (QA) manager who developed the company’s first formal Standard Operating Procedures (SOPs) and Sanitation Standard Operating Procedures (SSOPs) and expanded the company’s sanitation and environmental testing programs. Prior to 2016, the sanitation and quality assurance functions were handled by the production department.

In response to the violations detailed in the FDA warning letter, the company expanded its QA team, adding an assistant manager and technicians. It also conducted a comprehensive review and update of its Good Manufacturing Practices (GMPs) conducted training sessions for employees, and corrected other issues raised by FDA and WSDA inspectors during the inspections initiated in December 2017 and completed in January 2018.

When asked to comment on the remedies outlined in Darwin’s response letter, a spokesperson for FDA said “… we aren’t able to share … any information about discussions with firms regarding their responses to warning letters.”

FDA’s investigation remains open, according to the agency spokesperson.

FDA investigates Smucker-owned Big Heart over pentobarbital

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

An investigation into pentobarbital adulteration in canned, wet pet food manufactured by Big Heart Pet Brands Inc. remains “open and ongoing” according to a spokesperson for the U.S. Food and Drug Administration.

Big Heart is a wholly owned subsidiary of The J.M. Smucker Company Inc.

On Feb. 16, FDA alerted pet owners to the possible presence of pentobarbital in certain canned dog foods, including Gravy Train, Kibbles ’N Bits, Ol’ Roy and Skippy products, after a media outlet reported having found the chemical in several samples of Gravy Train canned, wet dog food.

Upon learning of the findings, Smucker initiated a product withdrawal pending the outcome of an internal investigation. The withdrawal was upgraded to a voluntary recall after the company verified the presence of pentobarbital in its finished products and in beef tallow, an ingredient common to all of the affected products.

Pentobarbital is a barbiturate used to euthanize animals. FDA considers a pet food to be adulterated if it contains even a trace amount of the drug.

On Feb. 23, FDA initiated an inspection of the Big Heart manufacturing facility in Bloomsburg, PA. The inspection was conducted jointly with the Pennsylvania Department of Agriculture (PDA) and was completed on March 12th.

According to information contained in the Establishment Inspection Report (EIR), obtained by Food Safety News in response to a Freedom of Information Act request, Big Heart produces dog food under contract for third-parties in addition to manufacturing the Gravy Train, Ol’ Roy, Kibbles ’N Bits, and Skippy dog food brands as well as several brands of cat food.

A spokesperson for FDA, citing the ongoing status of the investigation, declined to comment on whether any of the private-labeled products were evaluated for possible pentobarbital contamination. Nor would the spokesperson comment on whether FDA conducted its own independent analysis of any ingredients or finished products as part of its investigation.

Big Heart did not test any other ingredients for pentobarbital once it found the chemical in the beef tallow ingredient.

All of the beef tallow used in the adulterated pet food was obtained from a single supplier.

Big Heart notified its supplier of the test results and followed up with an inspection of the supplier’s facility. Concluding that the supplier did not have adequate controls over its supply chain, Big Heart management switched to a different tallow supplier. In addition, the company reconfigured some product formulas to eliminate beef tallow.

A class action lawsuit filed in Northern California on May 1 against Big Heart Pet Brands Inc. alleges that the tallow was supplied by MOPAC, an eastern Pennsylvania rendering facility belonging to JBS USA Holdings Inc.

JBS operates two facilities in eastern Pennsylvania, one in Souderton and the other in Elizabethville. FDA declined to comment on whether either or both of these facilities were included in the investigation.

According to information contained in Establishment Inspection Reports obtained in response to a Freedom of Information Act request, the Elizabethville location manufactures poultry feed.

JBS Souderton is a rendering operation. It receives bovine, porcine and avian trimmings, bone, hides, offal, and blood from its nearby slaughter/meat packing facility and from other slaughter facilities, and also receives used cooking oil and yellow grease from restaurants.

Souderton produces a number of animal feed ingredients, including tallow, blood-meal, feather-meal, bone-meal and animal protein.

During the February-March inspection of Big Heart, FDA and PDA investigators were denied access to several documents, according to the EIR.

On instruction from the Smucker corporate headquarters, Big Heart management refused to furnish PDA and FDA investigators with qualitative or quantitative product formulae and refused to permit them to review either the company’s consumer complaint files or its Standard Operating Procedures for retaining samples.

The Plant Director, Dave Brookover, also declined to sign, or even to read, an FDA Affidavit (FDA Form 463a) setting out the information supplied by him during the course of the inspection. On instructions from the corporate office, Brookover left the room when the FDA investigator recited the contents of the Affidavit.

Some companies have specific policies on what they will or will not share with FDA, a spokesperson for the agency explained, adding that the nature and number of refusals were not out of the ordinary and did not obstruct the investigation.