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. 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. Or emailed to: orahafwest5firmresponses@fda.hhs.gov. 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. JUMP TO: Primal Pet Foods Primal Patties For Dogs (2022) | Freshpet Fresh From The Kitchen Home Cooked Chicken Recipe (2022) |Family Dollar pet food recall (2022) | Woody's Pet Food Deli recall (2021) |Top Quality Dog Food recall (2021) | Sunshine Mills dog food recall (2021) | Natural Balance cat food recall (2021) | Meow Mix cat food recall (2021) | Midwestern Pet Foods recall (2021) | Albrights Raw Dog Food recall (2020) | Real Pet Food dog food recall (2020) | Sunshine Mills dog food recall (2020) | Natural Balance cat food recall (2020) | Texas Tripe raw pet food recall (2019) | Blue Ridge Beef kitten food recall (2018). While not required from a regulatory standpoint, we have enhanced our nutritional testing to include a Test & Hold program. If you bought the recalled product, you should stop feeding it to your dog and throw it away. Young children, elderly people, pregnant women, and those with weakened immune systems are particularly vulnerable to Listeria monocytogenes infections and symptoms can be more severe. Why it was recalled: One-pound packages of Beef HVM from Top Quality Dog Food were recalled for potential exposure to salmonella and listeria. 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. 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. 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. All dog food recipes are manufactured in the same production facility, which is USDA, and AAFCO approved and compliant with all food safety standards. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. and chemical preservatives in pet food offerings, and risks of a product recall will challenge the growth of the market participants. Some of our partners may process your data as a part of their legitimate business interest without asking for consent. . The recalled products are: Why it was recalled: Albrights Raw Dog Food recalled 67 cases of 2-pound rolls of its Chicken Recipe For Dogs because of potential salmonella contamination. The site is secure. Wash your hands after handling a recalled product. Or go to the FDAs Report a Pet Food Complaint page. Your response included a revised report of the validation study conducted by (b)(4) for the inhibition of Salmonella using (b)(4) with updated graphs and language. Request Free Sample Report. Pocket-Sized Kitten Grows Up To Be A Wild Woman. Listeria reportedly rarely causes illness in dogs, but if they are ill, it can cause symptoms like diarrhea and vomiting. This recall is being conducted in cooperation with the U.S. Food and Drug Administration. 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. vegetables, fruits, unrefined vitamins, and minerals. Pathogens in pet food can make people as well as pets sick. 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. Why it was recalled:Midwestern Pet Foods recalled all dog and cat food made with corn products that were produced at an operations facility in Chickasha, Oklahoma, due to excessive aflatoxin levels. 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 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. The contamination was discovered in packages with labeled lot #071521, which were distributed to Washington, D.C., Maryland, Virginia, Delaware, Pennsylvania, Massachusetts, Connecticut and South Carolina through mail order or direct delivery. This Primal recall is just one of over 39 recalls that have occurred in the past year. 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. If you bought a pet food that has an active recall, heres what you should do: As of this publish date, these are the active pet food recalls from 2022. This recall is being conducted in cooperation with the U.S. Food and Drug Administration. Lot code BEST BEFORE 10 2020, T1911125 3912, found 102,829 to 102,346 IU/kg of vitamin D in your canned dog food. The food was recalled after a state surveillance sample found salmonella and listeria in multiple 1-pound packages of Beef HVM. Primal dog food is not listed on the FDA's pet food recall website, and has not been involved in any recent recalls. In addition, your firm failed to reduce the likelihood the problem will recur as evidenced by your testing showing four lots of finished product found positive for pathogens after implementation of your corrective actions in response to the recall. 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. Primal is one of the few raw diet brands that make safe. For more details and other recalls, visit the table below. 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. Since the original recall announcement on Feb 8, 2023, Purina expanded the recall on March 10, 2023 to two additional product lots. Be the first to know about special promotions, new products, and more! FDA records indicate that as of the date of this letter, their facility is not registered with FDA. 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 The firm did not take appropriate corrective action when a preventive control, combination of preventive controls, or the food safety plan as a whole was found to be ineffective in order to identify and correct the problem, reduce the likelihood that the problem will recur, evaluate all affected animal food for safety, and when appropriate, reanalyze the food safety plan, as required. People can become sick by handling contaminated food or touching surfaces that have been exposed to Listeria monocytogenes. Primal Pet Foods is recalling a single lot of its frozen beef patty dog food after a sample tested positive for listeria. We have temperature tracking devices on all shipments to ensure storage requirements are met while being transported. 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). 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. Summary: This is a free-dried raw food formula that can be rehydrated using warm raw goat milk or water before consumption. The protein sources are organic and free of antibiotics, steroids, and hormones. Primal Dog Food Reviewed: Pros, Cons, and Ingredient Analysis. THRIFTY ADULT DOG FOOD: 12 lb. Your supplier approval has been reclassified as a supporting prerequisite program and finished product microbiological testing has been changed to a verification activity. The firm preventive controls for the hazard of pathogens were found to be ineffective; therefore, they are required to take corrective action to identify and correct the problem, reduce the likelihood the problem will recur, and evaluate all affected animal food for safety. We received your written response dated November 1, 2022. Opheli Garcia Lawler is a Staff Writer on the News team at Thrillist. Your firm failed to evaluate the safety of the products manufactured on the same date and line as the recalled lot. Matt tried feeding his dog a diet made of bones and raw food, and it saved his dog from renal failure. 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 your pet has been eating this food and shows signs of discomfort or illness please contact your veterinarian immediately. The company uses a test and hold protocol to ensure that all products test negative for harmful bacteria before being released for sale. The lots were produced with bone that was not ground to the specifications the company has set. Elevated levels of aflatoxin. 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. Anyone exhibiting symptoms after handling this product should contact their healthcare provider. 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. Your written response should be directed to: Sergio Chavez You can also send a message to the company here. Your response stated you are updating your food safety plan to add a sanitation preventive control and will review and update all associated procedures, checklists, and pre-operational instructions. Pet parents are also encouraged to follow all safe handling instructions on our packaging. Primal Pet Foods is committed to the quality and safety of its products. However, (b)(4) is not an applicable method for your process. FDA is concerned that they have been unable to find scientific data indicating that PAA at that level is safe for dogs and cats to consume. While we provide information resources and canine education, the content here is not a substitute for veterinary guidance. 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 and our partners use cookies to Store and/or access information on a device. Specifically, their firm adds (redacted) as a preventive control for pathogens for their freeze-dried products. The lot number on the product is #W10068709, with a best-buy date of 05/22/23. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. The ingredient list is very transparent and contains multiple healthy ingredients that can benefit your dogs health. A single lot of Raw Frozen Primal Patties for Dogs Beef Formula (6-pound) is being recalled. All rights reserved. These violations resulted in the issuance of an FDA Form 483. Primal Pet Foods has temperature tracking devices on all shipments of frozen product to ensure storage requirements are met while being transported. FDA laboratory analysis revealed these products to be contaminated with Salmonella. 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. To view the purposes they believe they have legitimate interest for, or to object to this data processing use the vendor list link below. BREAKING NEWS: Primal Pet Foods INC. has issued a voluntary recall of select lots of Primal Canine and Feline Freeze-Dried Poultry Formula. Primal Pet Foods is recalling certain Raw Frozen Primal Patties for Dogs Beef Formula because of potential Listeria monocytogenes contamination. Do Not Sell or Share My Personal Information. The .gov means its official.Federal government websites often end in .gov or .mil. 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. 4. During the current inspection, FDA Investigators noted they continue to use PAA as a pathogen mitigation step and they have increased their PAA concentration from (redacted) ppm to (redacted) ppm on the advice of their PAA supplier and a third-party laboratory. 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, They also conduct a test and hold procedure for all their products to ensure that they are free of harmful bacteria. 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. 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. Some pups may not show any symptoms if they develop listeria. At present, Primal Dog Food is a widely accepted pet food brand that has improved the health of innumerable dogs all over the world. ADVERTISEMENT Click the links in the table below to see the specific, important details about each recall. While the FDA was satisfied with our voluntary recall process and terminated the recall in late January 2023, they issued a Warning Letter to request additional information about our food safety plan. Help us keep pet food companies in check. *Caution letter, not a recall Dog Food Recall 2019 Full List All 2019 dog food recalls are listed in the table below. Why does Primal include fish in its Formula diets? This particular distribution center stores and ships products to 404 different Family Dollar stores, so pet food that was sent to any of those stores since January 1, 2022, has been recalled. Details for the recall are listed below. (You could get sick, too, if you dont wash your hands after handling it.). On behalf of our Primal team, I wanted to make you aware of a voluntary recall we are conducting on 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 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. No spam ever. Here is a list of the brands lines and recipes: Yes, Primal Dog Food has been recalled. An example of data being processed may be a unique identifier stored in a cookie. This formula is curated with fresh lamb, a rich source of delicious protein. Specifically, your reliance on your testing prerequisite program failed to reduce the probability that a nutrient deficiency or toxicity will occur in your pet food in the absence of a preventive control. For example, the lab report numbered 21-029-9570 with a sample received date of January 14, 2021, for the product Feline Chicken & Salmon Formula Freeze Dried (lot W10022504), reported thiamine levels based on dry weight as 3.96 mg/kg. The recalled products are: As of this publish date, theres only one active pet food recall from 2018. 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 . The two recalls were voluntary and didnt severely affect the health of any dogs. 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. Pet owners say this is quality organic produce that their dogs love and get excited for. All dog food recipes are manufactured in the same production facility, which is USDA, and AAFCO approved and compliant with all. 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. This is a grain-free formula and is also free of any legumes. 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. Their processing method is safe and complies with all USDA and. 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. 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 Dog Food is made in Fairfield, CA 94534, USA. By signing up, you agree to our Privacy Policy. Its pretty stressful to find out a pet food recall has been issued on your BFFs usual dinner. In February, the United States Food and Drug Administration (FDA) issued a warning letter to Primal Pet Foods after agency representatives inspected Primal Pet Foods' manufacturing facility in Fairfield, California in 2022. All recipes use organic vegetables, fruits, unrefined vitamins, and minerals. If youre not sure whether your pets food is affected by the recall, please visit the Primal Pet Foods INC website for batch details. The ingredients are carefully selected to make balanced meal recipes that improve dogs digestive, bone and heart health. Primal Dog Food is a premium dog & cat food brand, a part of Primal Pet Foods established in 2001 by Matt Koss. 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 . 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. Your firm does not perform cleaning between batches of the same recipe and only performs a (b)(4) when transitioning between different recipes. FDA has determined that their facility is subject to the registration requirement in the FD&C Act10 and its implementing regulations. However, their prerequisite program was either insufficient or they failed to implement it adequately to manage the hazard. There is no food additive regulation in 21 CFR Part 573 for the use of PAA in animal food, and PAA is not listed in 21 CFR Part 582 or 584 as a substance that is GRAS for the intended use. This Pregnant Pittie Foster Story Is The Happiest Thing Ever. Prior to the inspection, our food safety program included the following controls the use of high-quality, edible grade raw materials, inbound raw material testing, a supplier approval program, and a finished product Test & Hold protocol. According to a company release, 1 this recall is a result of routine sampling by the U.S. Food and Drug Administration, which discovered a positive result for Listeria monocytogenes in 1 sample from 1 lot of Raw Frozen Primal Patties for Dogs Beef Formula. Specifically, your firm adds (b)(4) as a preventive control for pathogens for your freeze-dried products. 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. You identified (b)(4) as the preventive control for frozen products and probiotic inclusion as the preventive control for freeze dried products. Ensure storage requirements are met while being transported 10 2020, T1911125 3912, found 102,829 102,346. If you dont wash your hands after handling this product should contact their healthcare provider cooperation the... Severely affect the health of any dogs balanced meal recipes that improve digestive...: Sergio Chavez you can also send a message to the company here using warm raw goat milk or before. Can be rehydrated using warm raw goat milk or water before consumption promotions, new products and! With bone that was not ground to the quality and safety of its Frozen Beef dog. 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