Be sure to thoroughly wash your hands and clean your pups bowls and any other surfaces the food touched. Safety Alerts, Raw Frozen Primal Patties for Dogs Beef Formula, An official website of the United States government, : FAIRFIELD, CALIF. The US Food and Drug Administration (FDA) on Feb. 21 issued a warning letter to Primal Pet Foods, Inc., regarding inspections of the company's Fairfield facility between July 14 and Oct. 11. FDA does not endorse either the product or the company. Warning letters often are not issued until a company has been given months to years to correct problems. Primal Pet Foods confirmed that all testing results on this single lot of recalled product were negative for Listeria monocytogenes (both raw materials and finished product) before it left its production facility. This program allows us to consistently monitor values and ensure that our food-based, non-synthetic supplements are routinely delivering the targeted nutrient levels. Pet parents are also encouraged to follow all safe handling instructions on Primal packaging and wash their hands and all preparation surfaces after handling any raw product. (According to the FDA, listeria infections arent too common in pets but can still happen.). If you have purchased the product you should immediately discard the product and stop feeding it to your dogs. Additionally, we recognize that more education about this innovative approach to pathogen control is necessary and will be working to provide more information to you and your team. All rights reserved. BREAKING NEWS: Primal Pet Foods INC. has issued a voluntary recall of select lots of Primal Canine and Feline Freeze-Dried Poultry Formula. In a Feb. 16 warning letter, the FDA described an Aug. 23 through Sept. 30, 2022 inspection of Arrow Reliance Inc.s pet food manufacturing facility in Tukwila, WA. Also, your validation study does not address the other pathogens you have determined to be hazards requiring a preventive control, such as E. coli O157:H7 and Listeria monocytogenes. Primal dog food uses bones, meat, and organ meat from these protein sources for its recipes. (You could get sick, too, if you dont wash your hands after handling it.). Primal Pet Foods has temperature tracking devices on all shipments of frozen product to ensure storage requirements are met while being transported. Symptoms in humans may include fever, headache, muscle aches, stiff neck, nausea, abdominal pain, diarrhea, confusion, loss of balance and convulsions. An indication the controls you implemented are not adequate is that FDA laboratory analysis detected Listeria monocytogenes in an FDA surveillance sample (number 1146079) of your pet food, Raw Frozen Primal Patties for Dogs Beef Formula, collected from retail on May 24, 2022, resulting in the July 6, 2022, Class I recall described above. Since the original recall announcement on Feb 8, 2023, Purina expanded the recall on March 10, 2023 to two additional product lots. Positive customer feedback on this pet supply ensures that this dog food is suitable for many dog breeds and life stages. All the ingredients are organic, and the formula is free of any additives. In our response to the FDA, we shared the detailed studies that validate probiotics as a preventive control for pathogens such as Salmonella and Listeria. Additionally, we added more sanitation preventive controls to our food safety plan and increased environmental monitoring swab sites in our facility. Your firm failed to evaluate the safety of the products manufactured on the same date and line as the recalled lot. Our Raw Frozen Primal Patties should be kept frozen until a pet parent is ready to use them. You'll have to look for lot number W10068709 and best by date 05/22/23 to determine whether or . People can become sick by handling. If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@fda.hhs.gov , or (949) 608-4496. However, we failed to provide the detailed scientific studies that demonstrate the effectiveness of probiotics in our freeze-dried and frozen products using our equipment parameters. The Dog Food Advisor first became aware of the warning on March 21, 2023. Affected products are 2-pound rolls from lot GA1102. Dogs with weak immune systems, like puppies, senior dogs or dogs with certain diseases or who are taking some medications, can be at higher risk for getting sick. This voluntary recall is a result of routine sampling by the U.S. Food and Drug Administration, which revealed a positive result for Listeria monocytogenes in one sample from one lot of Raw Frozen Primal Patties for Dogs Beef Formula. Primal Pet Foods has received no complaints or reports of illness to pets or humans due to this recalled product. A pet food can be recalled if: But just because something gets recalled doesnt necessarily mean that product is recalled forever. Furthermore, your study report also indicated you performed an enumeration of Salmonella by following FDAs Bacteriological Analytical Manual (BAM); however, FDA BAM does not have a method for Salmonella enumeration and the method used in the study is not able to detect 10 CFU/g of Salmonella. Additionally, you distributed this food before the lab had even received the samples, making it impossible for you to have destroyed the food in accordance with SOP-722. Details for the recall are listed below. You can also send a message to the company here. To view the purposes they believe they have legitimate interest for, or to object to this data processing use the vendor list link below. If pet parents have any questions, they can contact Primal Pet Foods by phone at (800) 742-1312 Monday-Friday, 6:00 a.m. through 4:00 p.m. PST, or by submitting an online request. Even if a dog is not showing symptoms, it can still be a carrier of the bacteria and spread it to humans. The ingredients are carefully selected to make balanced meal recipes that improve dogs digestive, bone and heart health. By signing up, you agree to our Privacy Policy. Want more Thrillist? No spam ever. From Balanced Bases to Toppers and Hydratorsexplore Primal Pet Foods to boost your dog or cat's meals for a happier and healthier life! After a review of your revised validation study report, FDA still concludes your study does not support your claim that the probiotic is an effective preventive control for Salmonella in freeze dried, raw beef; therefore, your response is inadequate. Specifically, their reliance on their testing prerequisite program failed to reduce the probability that a nutrient deficiency or toxicity will occur in their pet food in the absence of a preventive control. Their processing method is safe and complies with all USDA and. This inspection was conducted in response to a Class 1 recall initiated on July 6, 2022, of Raw Frozen Primal Patties for Dogs Beef Formula, lot number W10068709, due to the presence of Listeria monocytogenes detected in an FDA surveillance sample. Review: Based on 1,206 customer feedback on Amazon, this product has an average rating of 4.7 out of 5 stars. Dogs should eat according to their size. 4. The inspection followed a recall of the company's products in July 2022 predicated by the agency's detection of Listeria monocytogenes in Raw Frozen Primal Patties . If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. Paranoia Agent (Japanese: , Hepburn: Ms Dairinin) is a Japanese anime television series created by director Satoshi Kon and produced by Madhouse about a social phenomenon in Musashino, Tokyo caused by a juvenile serial assailant named Lil Slugger (the English equivalent to Shnen Bat, which translates to "Bat Boy").The plot relays between a large cast of people. The Salmonella found in the three lots of pet food described above causes them to be adulterated because the Salmonella may render the food injurious to health. Their processing method is safe and complies with all USDA and AAFCO standards. Aflatoxin is a toxin that comes from a mold that grows on corn, and exposure can be serious and even fatal for pets. We have always routinely reviewed and updated our food safety programs to ensure that we meet or exceed all regulatory requirements as well as the nutritional efficacy of our foods as set forth by our Product Development and Nutrition Teams. Please support The Animal Rescue Site by adding us to your ad blockers whitelist ads help us to provide food and vital supplies to shelter pets. In addition to the enhanced finished product nutritional testing, we have also increased the frequency of nutrient testing on raw materials to continuously validate that our natural, non-synthetic ingredients are delivering adequate and safe levels of required nutrients. In your Hazard Analysis at the Mix Supplements and Veggies step, you identified and evaluated the potential chemical hazard of the addition of Vitamin D and Thiamin as a significant hazard and determined it did not require a preventive control due to your testing prerequisite program. Tips, Cats, Primal states that they use high-pressure processing to prepare all their products, eliminating all pathogens from the food. The lot number and best by date can be found on the lower third of the back of the Raw Frozen Primal Patties package. If pet parents have any questions, they can contact Primal Pet Foods by phone at (800) 742-1312 MondayFriday, 6:00 a.m. through 4:00 p.m. PST, or by submitting an online request. This formula is curated with fresh lamb, a rich source of delicious protein. If youre not sure whether your pets food is affected by the recall, please visit the Primal Pet Foods INC website for batch details. In a Feb. 21 warning letter, the FDA described a July 14 through Oct. 11, 2022 inspection of Primal Pet Foods manufacturing facility in Fairfield, CA. To ensure that you make the best and safest choice for your dogs daily meals, we have reviewed and analyzed the most popular Primal Dog Food formulas you can find on Amazon & Chewy. Even if a dog is not showing symptoms, it can still be a carrier of the bacteria and spread it to humans. Violations resulted in the issuance of an FDA Form 483. b) Although you told the Investigator that you utilize the AAFCO Food Nutrient Profiles, the table on page 2 of your SOP-722 identified a minimum thiamine level of (b)(4) mg/kg based on a dry weight in feline diets. This Primal recall is just one of over 39 recalls that have occurred in the past year. If you have any questions, please view our recall FAQs or contact Primal Pet Foods by phone at (800) 742-1312 Monday-Friday, 6:00 a.m. through 4:00 p.m. PST, or by submitting an online request. Texas Tripe Chicken, Pork And Salmon With Egg. March 29, 2023 The Food and Drug Administration (FDA) posted a Warning Letter to Primal Pet Foods, Inc. of Fairfield, California. Why it was recalled: Natural Balance recalled its Ultra Premium Chicken & Liver Pat cat food after receiving reports of adverse reactions. Your animal food facility is subject to the Hazard Analysis and Risk-Based Preventive Controls requirements found in 21 CFR Part 507, subparts A, C, D, E, and F. During our inspection of your facility, the FDA Investigator observed evidence of significant violations of these requirements including, but not limited to, the following: 1. If you have this product in your possession, discontinue use immediately, and return the food to the purchaser for full credit. The complainant also provided documentation that a stool sample from one of the kittens tested positive for Salmonella spp. The protein sources are organic and free of antibiotics, steroids, and hormones. They also conduct a test and hold procedure for all their products to ensure that they are free of harmful bacteria. The Raw Frozen Primal Patties are sold in flexible packaging in the freezer at select pet stores. This voluntary recall is a result of routine sampling by the FDA, which revealed one positive result for Listeria monocytogenes in one lot (#W10068709) of Raw Frozen Primal Patties for Dogs Beef Formula. Here is the brands recall history: Primal is one of the few raw diet brands that make safe BARF food formulas. We expect the FDA to be fully satisfied with our response and the steps we are taking to ensure we continue to make raw food even safer for our consumers and their pets. Guidance for Industry #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals https://www.fda.gov/media/110477/download Furthermore, FDA is not aware of any data demonstrating that PAA is GRAS for any use in animal food. Primal Pet Foods has temperature tracking devices on all shipments of frozen product to ensure storage requirements are met while being transported. In addition, the firm failed to reduce the likelihood the problem will recur as evidenced by their testing showing four lots of finished product found positive for pathogens after implementation of their corrective actions in response to the recall. The product has lot number #W10068709 and a best by date of May 22, 2023. Alameda, CA 94502. The ingredients are carefully selected to make balanced meal recipes that improve dogs digestive, bone and heart health. Convenient and delicious raw nutrition that is shelf-stable and ready to serve. If your cat consumes an unsafe amount of choline chloride, he may experience symptoms like: This recall applies to 5.5-ounce cans with the lot code 9217803 and a best by date of August 4, 2021. An example of data being processed may be a unique identifier stored in a cookie. The safety and quality of our products has always been my top priority. However, their prerequisite program was either insufficient or they failed to implement it adequately to manage the hazard. Why does Primal include fish in its Formula diets? found 100,170 to 107,282 IU/kg of vitamin D in your canned dog food. This was issued after routine FDA sampling found listeria in food from one specific lot. July 6, 2022 Primal Pet Foods is recalling a single lot of Raw Frozen Primal Patties for Dogs Beef Formula due to potential contamination with Listeria monocytogenes bacteria. Pet parents are also encouraged to follow all safe handling instructions on Primal packaging and wash their hands and all preparation surfaces after handling any raw product. The specific products recalled include the 15-ounce container and the 5-pound tub, both of which have expiration dates of November 20, 2022. We have reviewed your response and we discuss your corrective actions below, in relation to each of the noted violations. The U.S. Food and Drug Administration (FDA) collected samples of their Darwins Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats and Darwins Natural Selections Antibiotic & Grain-Free Turkey Recipe for Cats in response to a consumer complaint received about their products causing illness in the customers kittens. Food uses bones, meat, and hormones our food-based, non-synthetic supplements are routinely delivering the targeted levels! Relation to each of the back of the warning on March 21, 2023 letters often are not until! You should immediately discard the product or the company to determine whether or food-based, non-synthetic supplements routinely! Possession, discontinue use immediately, and return the food to the purchaser for full credit is. Ensure storage requirements are met while being transported and line as the lot. With fresh lamb, a rich source of delicious protein Based on 1,206 customer feedback on this Pet ensures. 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primal dog food recall 2020