Both these diseases can make you or your dog really sick. Start your day with heartwarming and hilarious animal stories that will make you fall in love. (2) NUTRIENT TESTING. Alameda, CA 94502. Your written response should be directed to: Sergio Chavez Sunshine Mills, Inc. is expanding its voluntary recall of certain pet food products that were made with corn that . To view the purposes they believe they have legitimate interest for, or to object to this data processing use the vendor list link below. We are unable to fully evaluate the adequacy of your corrective actions since you did not provide supporting documentation to demonstrate these corrections have been completed and are being consistently implemented. 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). The lot number and best by date will be listed on the lower third of the bag. The site is secure. The. The food was recalled after the Minnesota Department of Agriculture found salmonella in a 5-pound bag of Sprout Sporting Dog Food during routine testing. To learn more about our product safety assurance and test and hold protocols, please click here. FDA does not endorse either the product or the company. Primal dog food uses bones, meat, and organ meat from these protein sources for its recipes. Primal Recall. The recipes use selected foods, making the ingredient list high-quality and transparent. 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. So, more pet foods than the ones listed below have been recalled in the past five years, but those recalls have since been terminated. In consideration as to whether their facility meets an exemption from the food facility registration requirement, FDA reviewed the definition of a retail food establishment. A retail food establishment sells food products from that establishment directly to consumers as its primary function. The letter was issued to the company on February 21, 2023 but was not made public by the FDA until March 14, 2023. 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. A large breed dog (up to 75 pounds) should eat up to 2 cups of dry food per day. 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. 2. People can become sick by handling. 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. The ingredients are carefully selected to make balanced meal recipes that improve dogs digestive, bone and heart health. The. Improves vision, bone health, and vitality in dogs. 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 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. Due to the raw nature of the formulas, there is much concern about the safety quotient of the diet, especially against harmful bacteria such as Salmonella spp. If a pet parent has product from this lot in their possession, they should stop feeding it to their dog and dispose of it immediately. Why it was recalled: Natural Balance recalled its L.I.D. The recall is only limited to food from a single lot. The two recalls were voluntary and didnt severely affect the health of any dogs. 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. No other lot codes or Primal products are impacted by this announcement. (You could get sick, too, if you dont wash your hands after handling it.). The ingredients are carefully selected to make balanced meal recipes that improve dogs digestive, bone and heart health. 20002023 The Animal Rescue Site and GreaterGood. We received your written response dated November 1, 2022. The Raw Frozen Primal Patties are sold in flexible packaging in the freezer at select pet stores. Funds are paid by Greater Good Charities to benefiting organizations as a grant. Pathogens in pet food can make people as well as pets sick. This post explains the nutritional question in detail. This product should be kept frozen until a pet parent is ready to use it. The FDAs inspection revealed that the firm was not in compliance with FDA regulations, specifically the FDAs Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals regulation. The FDA commented on the nutritional testing prerequisite program we had in place at the time of inspection. Your supplier approval has been reclassified as a supporting prerequisite program and finished product microbiological testing has been changed to a verification activity. TI1 3/APRIL/2020 TI2 3/APRIL/2020 TI3 3/APRIL . 2. During FDAs inspection, FDA reviewed their Grind Line Temperature Inspection form for (redacted) line (redacted) indicated their firm manufactured (redacted) products before and (redacted) products after the recalled lot. You did not identify and implement preventive controls to provide assurances that anyhazards requiring a preventive control will be significantly minimized or prevented, as required by 21 CFR 507.34(a)(1). Pocket-Sized Kitten Grows Up To Be A Wild Woman. ADVERTISEMENT Click the links in the table below to see the specific, important details about each recall. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Inspections, Compliance, Enforcement, and Criminal Investigations, Primal Pet Foods, Inc. - 645467 - 02/21/2023, https://www.fda.gov/media/110477/download, https://www.fda.gov/media/113923/download. 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. Primal Pet Foods is recalling certain Raw Frozen Primal Patties for Dogs Beef Formula because of potential Listeria monocytogenes contamination. 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 firm does not perform cleaning between batches of the same recipe and only performs a (redacted) when transitioning between different recipes. If you have this product in your possession, discontinue use immediately, and return the food to the purchaser for full credit. [See 21 CFR 507.34(a)(1)]. . Freshpet had been aware of the contamination and had planned to destroy the lot, but some of the affected food was accidentally sent to Walmarts in Alabama and Georgia, some Target locations and other retailers in Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Puerto Rico, Rhode Island, Vermont and West Virginia. Before sharing sensitive information, make sure you're on a federal government site. We responded in a timely manner and provided supporting documentation to demonstrate how our team is consistently implementing critical processes. Violations resulted in the issuance of an FDA Form 483. All recipes use organic vegetables, fruits, unrefined vitamins, and minerals. . The inspections were conducted in response to a recall of Primal's Raw Frozen Primal Patties for Dogs Beef Formula on July 6, 2022. 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. (3) VALIDATION OF PROBIOTICS. You'll have to look for lot number W10068709 and best by date 05/22/23 to determine whether or . The Primal Pet Foods recall: Which products are affected A single lot of Raw Frozen Primal Patties for Dogs Beef Formula (6-pound) is being recalled. All the ingredients are organic, and the formula is free of any additives. 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. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. If youre not sure whether your pets food is affected by the recall, please visit the Primal Pet Foods INC website for batch details. 331(uu)]. Listeria reportedly rarely causes illness in dogs, but if they are ill, it can cause symptoms like diarrhea and vomiting. 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. No other Primal lot codes or products are impacted by this voluntary recall. This program allows us to consistently monitor values and ensure that our food-based, non-synthetic supplements are routinely delivering the targeted nutrient levels. 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. Exactly 66 cases of this product were distributed in April 2022 to these locations: No other Primal Pet Foods products or lot numbers are affected by this recall. This is a grain-free formula and is also free of any legumes. Thank you. Your pups food is only affected if its got the UPC code 627975011673, the lot code 10/29/22 and the expiration date 10/29/22 L3. FDA records indicate that as of the date of this letter, their facility is not registered with FDA. 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. Review: Based on customer feedback, this Primal Beef Topper has an average rating of 4.8 out of 5 stars. 2 See Section 301(a) of the FD&C Act [21 U.S.C. March 29, 2023 The Food and Drug Administration (FDA) posted a Warning Letter to Primal Pet Foods, Inc. of Fairfield, California. 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. An example of data being processed may be a unique identifier stored in a cookie. 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. The FDA believed the hazard preventative controls we had in place at the time of the voluntary recall last July were not adequate. All rights reserved. Dogs can have mild symptoms such as diarrhea and vomiting. The good news is that Freshpet hadnt gotten any reports from customers about adverse reactions at the time of the recall. Primal Pet Foods is recalling a single lot of its frozen beef patty dog food after a sample tested positive for listeria. Affected products are 2-pound rolls from lot GA1102. Our mission is to provide pet parents just like you with the most up-to-date expert information and resources you need to make better, more informed decisions that support the health and happiness of your companion animals. Before sharing sensitive information, make sure you're on a federal government site. Veterinarians.org does not intend to provide veterinary advice. Common symptoms can range from mild to severe and include: Even if your dog seems fine, you should still talk to your vet if your pup ate some of the recalled product because he can still be a carrier for the bacteria and pass it on to you or other animals. U.S. citizens can report complaints about FDA-regulated pet food products by calling the consumer complaint coordinator in your area. 4. 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. Primal Pet Foods. If you start having abnormal symptoms, like fever, headache or muscle aches, contact your healthcare provider. This product should be kept frozen until a pet parent is ready to use it. . Tips, Cats, 535 Watt Drive, Suite B This makes Primal Dog Food a safe, 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 &, Minimally processed raw food with optimum nutrient levels, Contains lamb, which is a source of high protein, Contains superfoods like blueberries, pumpkin, and carrots. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. Failure to adequately address this matter may lead to legal action, including without limitation, seizure and injunction. Their processing method is safe and complies with all USDA and. Here is a list of the brands lines and recipes: Yes, Primal Dog Food has been recalled. 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. The inspection was conducted in response to a recall initiated on July 6, 2022, of Raw Frozen Primal Patties for Dogs Beef Formula because of the presence of Listeria monocytogenes found in an. Primal Pet Foods is committed to the quality and safety of its products. You can find the lot number and best by date on the back of the food packaging. Positive customer feedback on this pet supply ensures that this dog food is suitable for many dog breeds and life stages. 2, or contact your nearest FDA consumer complaint coordinator with any questions. 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. This recall was issued after one animal illness was reported. The United States Food and Drug Administration (FDA) inspected your pet food manufacturing facility located at 535 Watt Drive, Suite B, Fairfield, CA 94534-1790 from July 14 through October 11, 2022. This Pregnant Pittie Foster Story Is The Happiest Thing Ever. 3 See Section 301(uu) of the FD&C Act [21 U.S.C. Warning letters often are not issued until a company has been given months to years to correct problems. This protein-rich food topper has multiple probiotic strains that improve digestion and gut health in dogs. Routine sampling by the U.S. Food and Drug Administration found the bacteria Listeria monocytogenes, which can cause listeriosis (listeria), in one sample from one lot of this product. During FDAs inspection, our review of your Grind Line Temperature Inspection form for (b)(4) line (b)(4) indicated your firm manufactured (b)(4) products before and (b)(4) products after the recalled lot. 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. Ingesting elevated amounts of choline chloride could lead to illness or even death. Symptoms in humans may include fever, headache, muscle aches, stiff neck, nausea, abdominal pain, diarrhea, confusion, loss of balance and convulsions. The specific products recalled include the 15-ounce container and the 5-pound tub, both of which have expiration dates of November 20, 2022. If a dog has consumed the recalled product, pet parents are encouraged to consult their veterinarian. We and our partners use data for Personalised ads and content, ad and content measurement, audience insights and product development. A Letter from Matt Koss and Lindsay Meyers. At the close of the inspection, you were issued a Form FDA-483, Inspectional Observations. 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. If you feed your pup Raw Frozen Primal Patties for Dogs Beef Formula, you need to read this. If you bought the recalled product, you should stop feeding it to your dog and throw it away. This recall is being conducted in cooperation with the U.S. Food and Drug Administration. What's Being Recalled? They were distributed to select pet stores in the areas listed above. No other products Purina products have been impacted by this recall. We have received no complaints or reports of illness to pets or humans from this lot. Dogs should eat according to their size. MATT KOSSFounder and Chief Product Officer, LINDSAY MEYERS, CVTVice President, Quality Assurance, Nutrition & Regulatory Compliance, Voluntary Recall Announcement July 6, 2022. Raw food is the most appealing food for dogs as they are carnivores by nature. Canadians can report any health or safety incidents related to the use of this product by filling out the Consumer Product Incident Report Form. This Primal recall is just one of over 39 recalls that have occurred in the past year. You indicated the initial report from (b)(4) would be available in December 2022. 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. 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. Consumers with questions are invited to contact the company by phone at (800) 742-1312 MondayFriday, 6:00 a.m. through 4:00 p.m. PST, or by submitting an online request. Summary: A Primal freeze-dried formula of delicious and easy-to-digest food topper. All dog food recipes are manufactured in the same production facility, which is USDA, and AAFCO approved and compliant with all food safety standards. This recall is being conducted in cooperation with the U.S. Food and Drug Administration. As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Your pets deserve better. Dogs can have mild symptoms such as diarrhea and vomiting. Why it was recalled: Natural Balance recalled its Ultra Premium Chicken & Liver Pat cat food after receiving reports of adverse reactions. 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. Primal Dog Food Reviewed: Pros, Cons, and Ingredient Analysis. You may find the FD&C Act and FDAs regulations through links in FDAs home page at www.fda.gov. The safety and quality of our products has always been my top priority. 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. 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. 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 . 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. While the nutrient tests that the FDA noted were technically out of compliance, the slight variance was not a health concern for pets. 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