Sunshine Mills, Inc. is expanding its voluntary recall of certain pet food products that were made with corn that . The Dog Food Advisor first became aware of the warning on March 21, 2023. Tips, Cats, Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Since the original recall announcement on Feb 8, 2023, Purina expanded the recall on March 10, 2023 to two additional product lots. ADVERTISEMENT Click the links in the table below to see the specific, important details about each recall. Why it was recalled: One-pound packages of Beef HVM from Top Quality Dog Food were recalled for potential exposure to salmonella and listeria. All of the ingredients are carefully sourced and free of added hormones and steroids. After a customer complaint regarding a different product, the FDA took a sample of the Raw Cornish Hen Pet Food With Supplements and found salmonella. 1201 Harbor Bay Parkway See our advertising disclosure. Finally, your firm was not consistently testing the finished products for total Vitamin D (D2 and D3) levels, despite the fact that some of your ingredients contain Vitamin D2, which could contribute to elevated levels of Vitamin D in your dog food. The U.S. Food and Drug Administration (FDA) conducted a routine inspection of our Fairfield, California, facility following our voluntary recall of Raw Frozen Beef Patties last summer. Primal Pet Foods, Inc. of Fairfield, California has voluntarily recalled 9 of their freeze dried dog and cat food products following a product quality review. vegetables, fruits, unrefined vitamins, and minerals. Primal dog food uses bones, meat, and organ meat from these protein sources for its recipes. We worked closely with the FDA inspectors to review our existing food safety plan and identify enhancements to both policies and processes. However, (b)(4) is not an applicable method for your process. Dog and Cat Food. Your response also provided a protocol for a validation study to be conducted by (b)(4) for using (b)(4) as a preventive control for Listeria monocytogenes in freeze-dried products. This makes Primal Dog Food a safe raw dog food option. Pocket-Sized Kitten Grows Up To Be A Wild Woman. Please follow this link or see below for a letter from Matt Koss and Lindsay Meyers, CVT. TI1 3/APRIL/2020 TI2 3/APRIL/2020 TI3 3/APRIL . Small dogs (up to 10 pounds) should eat cup to cup of dry food per day. 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. Your written response should be directed to: Sergio Chavez Darla R. Bracy As a result, the company has recalled a single lot of 6-pound Raw Frozen Primal Patties for Dogs. A freeze-dried formula boosted with protein and superfoods that improve your dogs overall health. Pathogens in pet food can make people as well as pets sick. While we provide information resources and canine education, the content here is not a substitute for veterinary guidance. Your firms Standard Operating Procedure (SOP), SOP-722, Sampling Protocol for Thiamine and Vitamin D, identifies a maximum vitamin D3 level of (b)(4) IU/kg based on dry weight. *Caution letter, not a recall Dog Food Recall 2019 Full List All 2019 dog food recalls are listed in the table below. More info A food recall is issued when a product is unsafe for people to eat. Recalls, Market Withdrawals, & Safety Alerts, Recalls, Market Withdrawals and Safety Alerts, Recalls, Market Withdrawals, & Safety Alerts, Archive for Recalls, Market Withdrawals & Safety Alerts, Primal Pet Foods Voluntary Recalls a Single Lot of Raw Frozen Patties Beef Formula Due to Potential Contamination with Listeria Monocytogenes, Recent Recalled Product Photos on FDA's Flickr Photostream. You can find the lot number and best by date on the back of the food packaging. This protein-rich food topper has multiple probiotic strains that improve digestion and gut health in dogs. In the FDAs letter, FDA explained that any substances that may become part of their pet food, such as PAA, must be used as described in an animal food additive regulation, be generally recognized as safe (GRAS) for the intended use as defined by the FD&C Act, or should be otherwise not objectionable for use in animal food due to a definition in the AAFCO Official Publication. The foods listed include both dog and cat freeze-dried formulas, labeled Chicken, Duck, Turkey, and Chicken-Salmon, and come in 5.5 or 14 ounces. Primal Dog Food Reviewed: Pros, Cons, and Ingredient Analysis. However, your prerequisite program was either insufficient or you failed to implement it adequately to manage the hazard. The FDA reviewed your validation study for the use of (b)(4) as a preventive control for Salmonella in your freeze-dried beef products and we determined your validation study did not support your claim that the probiotic is an effective preventive control for Salmonella. We distributed sixty-six cases (396 units) of this product to Maryland, Georgia, Texas, and British Columbia, in late April 2022. Primal Dog Food uses fresh and raw ingredients with minimal processing for its recipes. The company distributed sixty-six cases (396 units) of this single lot of Raw Frozen Primal Patties to Maryland, Georgia, Texas, and British Columbia, in late April 2022. People can become sick by handling contaminated food or touching surfaces that have been exposed to Listeria monocytogenes. If you have product from this lot in your possession, we ask that you stop feeding it to your dog and properly dispose of it. Your Question Answered. FDA laboratory analysis of the sampled pet food products revealed the presence of Salmonella kentucky and Salmonella typhimurium in FDA sample 1179788, and Salmonella typhimurium in FDA sample 1179789. Theres no cost. The main ingredient of this formula is cage-free, fresh, and organic beef. 348(a)(2)], an unapproved food additive is unsafe and food containing an unsafe food additive is deemed to be adulterated. However, their prerequisite program was either insufficient or they failed to implement it adequately to manage the hazard. If a dog has consumed the recalled product, pet parents are encouraged to consult their veterinarian. Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Their processing method is safe and complies with all USDA and AAFCO standards. Details for the recall are listed below. Additionally, during the inspection of their facility, FDA collected a sample of their Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats, lot 9306, and FDA laboratory analysis revealed the presence of Salmonella typhimurium. You can also report your complaint by visiting the FDA's " Report a Pet Food Complaint. Beef is a premium source of protein and is balanced with sweet potatoes, cherry tomatoes, kale, and ginger: all of which are superfoods rich in vitamins and antioxidants. The recall states that the food was produced outside of our grind size specification of 1/8 which we have determined is the ideal size of ground bone to be fed to dogs and cats. Before sharing sensitive information, make sure you're on a federal government site. The ingredient list is very transparent and contains multiple healthy ingredients that can benefit your dogs health. Their hazard analysis determined pathogens (Salmonella spp., Listeria monocytogenes, and E. coli O157:H7) are a hazard requiring a preventive control at the following steps: Inbound Testing, Mix Probiotics, Supplements, and Veggies, and Outbound Testing. Their food safety plan identified the following preventive controls for the hazard of pathogens: Supply Chain: Approved Supplier, Probiotics, and Outbound Micro Testing. During the inspection, the firm provided finished product microbial test results for cat and dog food manufactured between Aug. 2021- Aug. 2022 showing 49 products tested positive for Listeria monocytogenes or Salmonella spp. We are unable to fully evaluate the adequacy of your corrective actions since you did not provide adequate supporting documentation to demonstrate these corrections have been completed and consistently implemented. Canadians can report any health or safety incidents related to the use of this product by filling out the Consumer Product Incident Report Form. Your firm distributed the Feline Chicken & Salmon Formula Freeze Dried (lot W10022504) with a low thiamine level on January 11, 2021.Additionally, you distributed this food before the lab had even received the samples, making it impossible for you to have reworked the food in accordance with SOP-722, even if you had been aware of a low level of thiamine. This is a minimally processed freeze-dried food formula devoid of any corn, wheat, soy, or fillers. There are two major types of pet food recalls: voluntary recalls, which are issued by the company, and ordered recalls, which come directly from the FDA. 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. Specifically, their firm adds (redacted) as a preventive control for pathogens for their freeze-dried products. Based on conversations our team members have had with many of you over the last week, we are providing additional details about the content of the FDAs Warning Letter and the steps we have taken to continuously strengthen our food safety plan. 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. Warning letters often are not issued until a company has been given months to years to correct problems. Weve also increased the frequency of our nutrient testing process to ensure this doesnt happen again. A large breed dog (up to 75 pounds) should eat up to 2 cups of dry food per day. They market their formulas as being 100% "human-grade" raw foods and treats. The. Review: Based on customer feedback, this Primal Beef Topper has an average rating of 4.8 out of 5 stars. fda.gov Even if a dog is not showing symptoms, it can still be a carrier of the bacteria and spread it to humans. Primal Pet Foods has temperature tracking devices on all shipments of frozen product to ensure storage requirements are met while being transported. 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. Do Not Sell or Share My Personal Information. Theres been a recall on this product due to contamination from the bacteria that causes listeria. Overall, Primal Dog Food is a good choice of nutritious and healthy food for dogs. As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Simply crumble the freeze-dried nuggets and rehydrate with water, Bone Broth, or Raw Goat Milk. Based on recent conversations we have had with many of our retail partners, we areproviding additional detailsabout the content of the FDAs Warning Letter and the steps we have taken to continuously strengthen our food safety plan. What is the pH of your foods? This. Guidance for Industry #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals https://www.fda.gov/media/110477/download 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 lot number on the product is #W10068709, with a best-buy date of 05/22/23. You indicated the initial report from (b)(4) would be available in December 2022. Just for Fun. The affected products were from lot #W10068709 and have a best by date of 05/22/23. The recipes use selected foods, making the ingredient list high-quality and transparent. Primal Recall. The firm failed to sufficiently assess the probability that a hazard will occur in the absence of preventive controls, as required. In addition, you are updating your good manufacturing practices and will provide training on your new procedures, increase your environmental monitoring swab sites, and will provide training on your CAPA procedures. Additionally, the directions for use outlined on the label of the PAA product they use allow for a maximum concentration of 220 ppm of PAA on a ready-to-eat (cooked) human food. If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@fda.hhs.gov , or (949) 608-4496. Probiotics present in treated freeze-dried raw beef samples contain high levels of background flora which can suppress the growth of Salmonella and decrease the sensitivity of detecting Salmonella. When it was recalled: July 6, 2022 Why it was recalled: Primal Pet Foods recalled 6-pound packages of the beef formula of their raw frozen Primal Patties For Dogs due to possible listeria contamination. Office of Human and Animal Food Operations- West Division 5, CC: Matthew Koss, Founder/Chief Product Officer via email @ Matt@primalpetgroup.com. a) The lab report numbered 21-124-9881 with a sample received date of April 23, 2021, for the product Canine Turkey & Sardine Formula Freeze Dried (lot W10031394) reported Vitamin D3 levels, based on dry weight, as 3,410 IU/kg. The Raw Frozen Primal Patties are sold in flexible packaging in the freezer at select pet stores. By signing up, you agree to our Privacy Policy. On July 13, 2022, prior to the inspection of the firms facility, FDA collected and analyzed unopened samples of their Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats, lot 9116, and Natural Selections Antibiotic & Grain-Free Turkey Recipe for Cats, lot 9121, from one of their customers after receiving a complaint from the customer that three kittens developed diarrhea after consuming the food. Follow her on Twitter @opheligarcia and Instagram @opheligarcia. This formula is curated with fresh lamb, a rich source of delicious protein. Its pretty stressful to find out a pet food recall has been issued on your BFFs usual dinner. This was issued after routine FDA sampling found listeria in food from one specific lot. You failed to sufficiently assess the probability that a hazard will occur in the absence of preventive controls, as required by 21 CFR 507.33(c)(1). People can become sick by handling contaminated food or touching surfaces that have been exposed to Listeria monocytogenes. Primal Pet Foods is voluntarily recalling a single lot (#W10068709) of Raw Frozen Primal Patties for Dogs Beef Formula (6-pound), with best by date of 05/22/23, due to potential contamination with . Summary: This is a free-dried raw food formula that can be rehydrated using warm raw goat milk or water before consumption. Opheli Garcia Lawler is a Staff Writer on the News team at Thrillist. Subscribe to The Dog Food Advisors emergency recall warning system. Violations resulted in the issuance of an FDA Form 483. The firms Director of Quality informed FDAs Investigators that the majority of their product (approximately (redacted) percent) is shipped directly to consumers from third-party warehouses rather than from their facility. Get free dog food recall alerts sent to you by email. At present, Primal Dog Food is a widely accepted pet food brand that has improved the health of innumerable dogs all over the world. The inspections were conducted in response to a recall of Primal's Raw Frozen Primal Patties for Dogs Beef Formula on July 6, 2022. Like some other dog food formulas, Primal Pet Foods says that their formulas closely imitate the diet of dogs in the wild. Primal Pet Foods is committed to the quality and safety of its products. 20002023 The Animal Rescue Site and GreaterGood. Summary: A Primal freeze-dried formula of delicious and easy-to-digest food topper. Primal Dog Food makes several product lines. Some letters are not posted for public view until weeks or months after they are sent. Specifically, on July 6, 2022, their firm recalled Raw Frozen Primal Patties for Dogs Beef Formula, lot W10068709, with a production date of (redacted), after an FDA surveillance sample of the lot revealed the presence of Listeria monocytogenes. 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. Guidance for Industry #246: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply Chain Program https://www.fda.gov/media/113923/download. As of this publish date, theres only one active pet food recall from 2019. After FDA testing, products with salmonella bacteria all came from the same batch they have the lot code C000185 and a May 19, 2021 best by date. Primal states that they use high-pressure processing to prepare all their products, eliminating all pathogens from the food. This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. When a pet food is recalled, its taken off the market by the U.S. Food and Drug Administration (FDA). Your supplier approval has been reclassified as a supporting prerequisite program and finished product microbiological testing has been changed to a verification activity. 331(a)]. Positive customer feedback on this pet supply ensures that this dog food is suitable for many dog breeds and life stages. For more information about FDAs current thinking on the requirements of 21 CFR Part 507, see: Guidance for Industry #235: Current Good Manufacturing Practice Requirements for Food for Animals https://www.fda.gov/media/97464/download Or go to the FDAs Report a Pet Food Complaint page. The .gov means its official.Federal government websites often end in .gov or .mil. 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. Overall, Primal Dog Food is a good choice of nutritious and, 2022 Veterinarian.org, LLC. 2, or contact your nearest FDA consumer complaint coordinator with any questions. To make the most of the. We are unable to further evaluate this corrective action until we can review the final study report. HAF Division West 5 Salmonella can affect animals eating the product and there is a risk to humans, notably children, the elderly and the immunocompromised, when handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or surfaces exposed to these products. (To sign up for a free subscription to Food Safety News, click here. It is their responsibility to ensure their pet foods are safe before marketing them. The complainant also provided documentation that a stool sample from one of the kittens tested positive for Salmonella spp. An indication the controls they implemented are not adequate is that FDA laboratory analysis detected Listeria monocytogenes in an FDA surveillance sample of their 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. March 29, 2023 The Food and Drug Administration (FDA) posted a Warning Letter to Primal Pet Foods, Inc. of Fairfield, California. 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. (According to the FDA, listeria infections arent too common in pets but can still happen.). If you feed your pup Raw Frozen Primal Patties for Dogs Beef Formula, you need to read this. If you have any questions, please view our recall FAQs or 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. Selective enrichment broths for samples with high levels of probiotics help facilitate the growth of Salmonella while also suppressing the growth of the background flora without decreasing the sensitivity of detecting Salmonella. If you bought the recalled product, you should stop feeding it to your dog and throw it away. If you have this product in your possession, discontinue use immediately, and return the food to the purchaser for full credit. Like all Purina One True Instinct dog food recipes, this product relies on a high-quality animal protein source and a combination of healthy whole grains to supply starches and slow-release carbs. This recall includes the following products: According to Sunshine Mills announcement, products with other lot codes werent affected and the company hasnt identified the cause of the salmonella exposure. View all 8 Product Benefits 5 What benefits might my pet experience from eating a raw food diet? FDA has determined that their facility is subject to the registration requirement in the FD&C Act10 and its implementing regulations. Medium breed dogs (up to 25 pounds) should eat between 1 cup and 2 cups of dry food per day. Funds are paid by Greater Good Charities to benefiting organizations as a grant. Symptoms of aflatoxin poisoning include: According to the companys announcement, this recall was issued out of an abundance of caution, and only applies to those products from that specific facility in Chickasha that have expiration dates on or before July 9, 2022. If your dog has consumed the Primal Pet Foods Raw Frozen Primal Patties for Dogs Beef Formula that has the product number #W10068709 and 05/23/23 listed as the best by date, you are encouraged to contact a veterinarian. Primal Pet Foods has received no complaints or reports of illness to pets or humans due to this recalled product. You can also email Primal Pet Foods INC at support@primalpetfoods.com, call 1-866-566-4652 EXT. The FDA believed the hazard preventative controls we had in place at the time of the voluntary recall last July were not adequate. Primal Pet Foods Primal Patties For Dogs (2022), Freshpet Fresh From The Kitchen Home Cooked Chicken Recipe (2022), Blue Ridge Beef kitten food recall (2018), Raw Cornish Hen Pet Food With Supplements, recalled its L.I.D. 3. 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. 4. Primal Dog Food is a premium dog & cat food brand, a part of Primal Pet Foods established in 2001 by Matt Koss. 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 food was recalled after a state surveillance sample found salmonella and listeria in multiple 1-pound packages of Beef HVM. 1. This program allows us to consistently monitor values and ensure that our food-based, non-synthetic supplements are routinely delivering the targeted nutrient levels. 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 . The lots were produced with bone that was not ground to the specifications the company has set. FDA inspected the firms facility in June 2021, and subsequently sent them a letter dated Aug. 27, 2021, documenting our concerns with their use of PAA as a pathogen mitigation step to reduce E. coli O157:H7 and Salmonella spp. According to the company, 66 cases of food from this lot had been distributed to Maryland, Georgia, Texas and British Columbia. Aflatoxin is a toxin that comes from a mold that grows on corn, and exposure can be serious and even fatal for pets. The product has lot number #W10068709 and a best by date of May 22, 2023. Request Free Sample Report. All dog food recipes are manufactured in the same production facility, which is USDA, and AAFCO approved and compliant with all food safety standards. Do you use the whole apple including core and seeds in your formulas? The 2022 expansion of this recall now includes certain 2014 through 2020 Indian Heavyweight Air-Cooled Motorcycles, including the Chief, Chief Classic, Chief Dark Horse, Chief Vintage, Springfield. To view the purposes they believe they have legitimate interest for, or to object to this data processing use the vendor list link below. Withdrawals, & Elevated levels of aflatoxin. You identified (b)(4) as the preventive control for frozen products and probiotic inclusion as the preventive control for freeze dried products. Anyone exhibiting symptoms after handling this product should contact their healthcare provider. You can find the lot number and best by date on the back of the food packaging. Why it was recalled:Sunshine Mills recalled some dog food products because of the possibility that it contains excessive levels of aflatoxin. . This recall was issued after one animal illness was reported. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. The products in question were ground at 1/4 or 1/8 deviation from our specification. Although the recall contains an apology for any inconvenience this may cause you or your pet, it does not specify any symptoms to look for. We have reviewed your response and we discuss your corrective actions below, in relation to each of the noted violations. What's Being Recalled? You also stated that if any product tests positive on a particular shift, all product manufactured on that shift will be sent for rework. 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