• Olymel S.E.C./ L.P. Recalls Pork Products Produced Without Benefit of Import Inspection
  Olymel S.E.C./ L.P., an Alberta, Canada establishment, is recalling approximately 4,618 pounds of raw intact pork products because the products were imported from Canada and not presented for import re-inspection upon entry into the United States.
• Updated information is now available. A list of retail consignees has been posted for recall 007-2018,  Whip City Jerky, LLC Recalls Beef Jerky Products Due to Misbranding and an Undeclared Allergen (Feb 1, 2018)

• Updated information is now available. A list of retail consignees has been posted for recall 007-2018,  Whip City Jerky, LLC Recalls Beef Jerky Products Due to Misbranding and an Undeclared Allergen (Feb 1, 2018).

• Kareway Products, Inc is voluntarily recalling 60,000 lots of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial contamination which compromises sterility.Risk Statement: The product potentially could be calamitous for any population due to a probability of a potentially sight threatening eye infection or impairment. Kareway Products, Inc has not received any reports of adverse events related to this recall.The product is used as eye wash to clean, refresh, soothe eyes for daily use or emergency eye cleansing by flushing foreign material. It is packaged in 4 fluid ounce (118 ml) bottles. The affected Gericare Eye Wash, Sterile Eye Irrigation Solution lots include the following Lot#86041601 and expiration date of 09/2019. The product can be identified by UPC 3-57896-18604-3. The product was distributed Nationwide to wholesale businesses.Kareway Products, Inc is notifying its distributors and customers by recall letter and is arranging for return or disposal of all recalled products. Consumers and businesses that have product which is being recalled should stop using and selling them immediately.

  Consumers with questions regarding this recall can contact the Recall Department at 310-532-0009 or recall@kareway.com available Monday through Fridays from 08:30 am to 05:30 pm (Pacific Time). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

  Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

  This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

• Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA’s request. FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel.Between January 1, 2007, and November 9, 2017, FDA received 30 adverse event reports of elevated liver function tests or acute hypersensitivity pneumonitis associated with the use of Limbrel products. These conditions present in rare cases with varying degrees of severity in patients taking Limbrel for the first time in the initial weeks of exposure, and may go unnoticed by the patient until they consult with their physician or until symptoms develop that require hospitalization. There have been no deaths reported with the use of Limbrel, and in all reported cases adverse effects resolved without residual effects after discontinuing use of the product.Primus retained independent medical and former senior FDA safety experts to conduct a further investigation of these cases and the ingredients in Limbrel.  It is the opinion of these experts based on a thorough review of the medical literature, adverse event reports to FDA, and FDA’s health hazard evaluation that there is no basis on which to conclude that Limbrel potentially causes life-threatening adverse effects, and that none of the reported adverse events show liver failure or respiratory failure. Nonetheless, in an effort to cooperate with FDA, Primus voluntarily ceased its promotion and distribution of Limbrel on December 21, 2017, and is now recalling Limbrel as FDA has requested.All lots within expiry of the following products are included in this recall:
  • Limbrel (flavocoxid) 250 mg capsules, Product Identity Number 68040-601-16
  • Limbrel250 (250 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules, Product Identity Number 68040-605-16
  • Limbrel (flavocoxid) 500 mg capsules, Product Identity Number 68040-602-16
  • Limbrel500 (500 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules, Product Identity Number 68040-606-16

  Limbrel has been marketed since 2004 as a medical food available only by prescription for patients under active and ongoing supervision of a physician for the dietary management of osteoarthritis (OA), a degenerative disease of the joints and the most common form of arthritis. Prior to marketing, Primus conducted clinical studies that support the efficacy and safety of Limbrel and compiled an extensive dossier providing an analysis of published data to support the medical food status of Limbrel and to establish how the product meets the distinctive nutritional requirements of OA.  Primus stands by the legal status of Limbrel as a medical food. Limbrel products have been distributed nationwide in the USA to wholesalers, pharmacies, and physicians as medical foods without challenge from FDA for over 13 years, with approximately 2 million prescriptions and physician samples dispensed to an estimated 450,000 patients.

  Primus is notifying its distributors by emailed letter and is arranging for the return of all recalled products. Retail pharmacies that have Limbrel products should return them to the wholesale distributor.  FDA has recommended that patients who have the Limbrel products that are being recalled should stop use.

  Patients who wish to return unopened bottles or who have questions regarding this recall should go to Limbrel.com or contact Primus by calling (480-483-1410) on Monday through Friday, 9 AM to 5 PM Mountain Time. Patients should contact their physician or healthcare provider if they have experienced any adverse event that may be related to taking Limbrel.

  Physicians with extensive experience with Limbrel have provided written testimony to FDA confirming the benefits and safety of Limbrel for managing OA and to establish the medical necessity of Limbrel for elderly patients with comorbidities who cannot use NSAIDs and have a strong desire to avoid opioid use if possible.  For these and other patients and their medical professionals who have stated their desire for continued access to Limbrel, Primus will seek to work with FDA to return Limbrel to the market as quickly as possible.  For updates about access to Limbrel go to Limbrel.com.

  Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm.
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800- 332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

  This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

• PANERA BREAD PREEMPTIVELY RECALLS ALL 2 OZ. and 8 OZ. CREAM CHEESE PRODUCTS

  ST. LOUIS, January 28, 2018 – While there have been no reported illnesses, out of an abundance of caution, Panera Bread is conducting a nationwide preemptive, voluntary recall of all 2 oz. and 8 oz. cream cheese products sold in its U.S. bakery-cafes.  This recall was initiated after samples of one variety of 2 oz. cream cheese from a single production day showed a positive result for the presence of Listeria monocytogenes. Tests on cream cheese samples manufactured both before and after the production run in question have all come back negative.

  Despite the finding in only one day of production, Panera Bread is issuing a voluntary recall of all varieties of the 2 oz. and 8 oz. cream cheese.  The products included in the recall are all varieties (see below) of unexpired 2 oz. and 8 oz. cream cheese products with an expiration date on or before 4/2/18. This recall only affects cream cheese sold in Panera Bread United States bakery cafes and does not affect Panera Bread Canadian bakery cafes or any other Panera Bread food products.

  “The safety of our guests and associates is paramount, therefore we are recalling all cream cheese products sold in the US with an active shelf life.  We have likewise ceased all manufacturing in the associated cream cheese facility,” said Blaine Hurst, Panera’s President and CEO.  “Only one variety of 2-oz cream cheese from a single day yielded the positive result. Our intent is to go above and beyond for our guests. You should expect nothing less from Panera.”

  According to the FDA, Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

  Affected 2 oz. Cream Cheese Varieties (example pictured below):  Plain Cream Cheese, Reduced-Fat Plain Cream Cheese, Reduced-Fat Chive & Onion Cream Cheese, Reduced-Fat Honey Walnut Cream Cheese, Reduced-Fat Wild Blueberry Cream Cheese.

  

  Affected 8 oz. Cream Cheese Varieties (example pictured below): Plain Cream Cheese, Reduced-Fat Plain Cream Cheese, Reduced-Fat Chive & Onion Cream Cheese, Reduced-Fat Honey Walnut Cream Cheese, Reduced-Fat Wild Blueberry Cream Cheese.

  

  Consumers in possession of these products should discard them immediately and contact Panera Bread Customer Service at 1-855-6-PANERA from Monday through Sunday, 5:00 AM to 10:00 PM. CST, or visit Panera.custhelp.com for a full refund.

  Please click here for more information.

• Orange Cream Bars and Chocolate Coated Vanilla Ice Cream Bars (January 9, 2018)

  Fieldbrook Foods Corporation recalls orange cream bars, chocolate coated vanilla ice cream bars, and variety packs that included these ice cream bars because they could be contaminated with Listeria monocytogenes. The ice cream bars were sold under a variety of brand names and sold at stores such as Fred Meyer, Dollar Tree, and Kroger.

  Ice Cream Bars recall press release and product photos.

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  Hempler’s Family Classic Pepperoni (January 4, 2018)

  Hempler Foods Group, LLC, recalls Hempler’s brand “Family Classic Pepperoni” because it may be contaminated with metal.

  Hempler’s Family Classic Pepperoni recall news release and product labels.

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  Shredded Coconut (January 3, 2018)

  Evershing International Trading Company recalls Coconut Tree Brand frozen “Shredded Coconut – Dùa Bào” because it could be contaminated with Salmonella. This product is linked to an outbreak of Salmonella infections.

  Shredded Coconut recall press release and product photo.

  Multistate Outbreak of Salmonella Infections Linked to Shredded Coconut, CDC

•  Updated information is now available. A list of retail consignees has been posted for recall 006-2018,  Rich Products Corporation Recalls Beef Products due to Possible Listeria Contamination (Jan 24, 2018).
• National Frozen Foods Corporation (NFFC) is voluntarily recalling a limited quantity of Not-Ready-To Eat Individually Quick Frozen (IQF) green beans and IQF mixed vegetables because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.Following cooking preparation instructions on the labels of master cases or packages will effectively reduce the risk of exposure to this bacteriumThis press release includes recalled products distributed to foodservice accounts in bulk and packaged containers in AK, AR, AZ, CA, CO, FL, ID, IL, KS, MI, MS, MT, ND, NE, NM, NV, OR, TN, TX, VA, and WA. The products being recalled listed below were distributed between August 18, 2017 and January 12, 2018.The recalled items can be identified by the date codes printed on the back of the 32oz. sized bag or the side of the master case. Only the following codes are affected by this recall:* The 32 oz. inner clear poly bag has only lot code printed.The recall was initiated based on a 3rd party test result of the IQF Green Beans only by a downstream customer that revealed that the finished products may potentially be contaminated with the bacteria. There has been no report of human illness to date.The frozen green beans and frozen mixed vegetables are being recalled as a precaution with the health and safety of consumers as top priority and in full cooperation with the FDA. The recall has not yet been classified by the FDA.Consumers should not consume these products. Consumers who purchased affected products may return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-253-8269, Monday – Friday 7:30 a.m. to 4 p.m. (Pacific Time).
• Rich Products Corporation Recalls Beef Products due to Possible Listeria Contamination
  Rich Products Corporation, a Vineland, N.J. establishment, is recalling approximately 3,420 pounds of beef meatball products that may be adulterated with Listeria monocytogenes.
• FSIS Issues Public Health Alert for Chicken and Pork Products Produced without the Benefit of Inspection
  The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) is issuing a public health alert because Pigeon Caterers, Inc., doing business as Carnival Brands, a New Orleans, La. establishment, produced and distributed approximately 140 pounds of a chicken and pork product without the benefit of federal inspection.
• JustFoodForDogs (JFFD) of Los Alamitos, CA, is voluntarily recalling its Beef & Russet Potato, Fish & Sweet Potato and Turducken dog food meals in all sizes. JFFD uses 100% USDA and other restaurant grade ingredients in all of its pet food, and because the green beans used in these meals may be contaminated with Listeria monocytogenes, the companyis alerting the public. Listeria monocytogenescan affect animals eating the product and there is risk to humans if they were to intentionally or unintentionally ingest the dog food or come into contact with contaminated feces from a pet that has eaten the food.Listeriosis is rare in dogs and when infected most dogs have mild symptoms such as diarrhea and vomiting, however, more serious symptoms are possible, such as fever, muscular and respiratory signs, abortion and even death. In addition to the possibility of becoming sick, such infected animals can shed Listeria monocytogenes through their feces and thus serve as a source of infection to humans, especially if they have not thoroughly washed their hands. If your dog has consumed the recalled products and has these symptoms, please contact your veterinarian.Healthy people infected with Listeria monocytogenes should monitor themselves for some or all of the following symptoms if they believe they may have consumed any of the above recalled items intentionally or unintentionally, or may have come into contact with contaminated feces from a pet that has eaten the food: nausea, vomiting, diarrhea, aches and fever. Rarely Listeria monocytogenes can result in more serious ailments including arterial infections, endocarditis and can be life threatening. Pregnant women are more susceptible to Listeria infection, which can result in abortion. The most common way that people are affected is by consumption of contaminated food. Consumers exhibiting these signs after consuming this product should contact their healthcare provider.The recalled JFFD Beef & Russet Potato, Fish & Sweet Potato and Turducken was distributed only through 11 JFFD retail locations in Southern California, 3 Pet Food Express (PFE) locations in Southern California and 10 Northern California PFE locations.While testing demonstrates that only several dates of production were affected, out of an abundance of caution, JFFD is recalling all of the above mentioned products made from the dates of November 1, 2017 through January 14, 2018. These represent Best By lot code dates on all three of the JustFoodForDogs’ recalled products of 11/01/18 through 01/14/19.The products being recalled were sold refrigerated or frozen and include all sizes offered – 7 oz, 14 oz, 18 oz and 72 oz.No confirmed Listeriosis has been reported but there have been reports of short-term symptoms in some dogs (diarrhea and vomiting).There have been no reports of human illness to date.The potential for contamination was discovered after a purchaser of JFFD products reported to JFFD veterinary medical staff that her dogs had become ill. Tests to date confirm that green beans purchased from a restaurant supply distributor were positive for Listeria monocytogenes.The restaurant supplier/distributor of these green beans has voluntarily put a “product hold” on the distribution of these green beans to restaurants and other human food retailers.JFFD is currently making these recipes available without green beans until the matter is resolved.JFFD notified and is working with FDA on this matter.Consumers who have purchased the recalled JFFD products from a JFFD store should contact JFFD at 866-726-9509, from 9:00 AM – 7:00PM PST seven days a week, for a full credit or refund. Consumers who have purchased the recalled products from Pet Food Express should return them to any Pet Food Express for a full credit or refund.
• Arthri-D, LLC is recalling its Dietary Supplement “Arthri-D 120ct” Lot#1701-092 (the “Product”) because it may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.The Product was distributed nationwide through mail orders. It comes in a 225 cc, white plastic HDPE bottle marked with lot #1701-092 on the label and with a manufacturing date of March 2017 stamped on the side.No illnesses have been reported to date in connection with the Product.The potential for contamination was noted after routine testing by the company revealed the presence of Salmonella in 1 bottle. We have tested and re-tested the Product and no presence of Salmonella was subsequently found. However, out of abundance of caution, we have decided to recall this Product.Distribution of the Product has been suspended while FDA and the company continue their investigation as to the source of the Salmonella presentin that aforementioned 1 bottle.Consumers who have purchased 120 count of Arthri-D lot#1701-092 are urged to return them to the place of purchase for a full refund. Consumers with additional questions may contact the company at 978-992-0505.

JustFoodForDogs (JFFD) of Los Alamitos, CA, is voluntarily recalling its Beef & Russet Potato, Fish & Sweet Potato and Turducken dog food meals in all sizes. JFFD uses 100% USDA and other restaurant grade ingredients in all of its pet food, and because the green beans used in these meals may be contaminated with Listeria monocytogenes, the companyis alerting the public. Listeria monocytogenescan affect animals eating the product and there is risk to humans if they were to intentionally or unintentionally ingest the dog food or come into contact with contaminated feces from a pet that has eaten the food.

Listeriosis is rare in dogs and when infected most dogs have mild symptoms such as diarrhea and vomiting, however, more serious symptoms are possible, such as fever, muscular and respiratory signs, abortion and even death. In addition to the possibility of becoming sick, such infected animals can shed Listeria monocytogenes through their feces and thus serve as a source of infection to humans, especially if they have not thoroughly washed their hands. If your dog has consumed the recalled products and has these symptoms, please contact your veterinarian.

Healthy people infected with Listeria monocytogenes should monitor themselves for some or all of the following symptoms if they believe they may have consumed any of the above recalled items intentionally or unintentionally, or may have come into contact with contaminated feces from a pet that has eaten the food: nausea, vomiting, diarrhea, aches and fever. Rarely Listeria monocytogenes can result in more serious ailments including arterial infections, endocarditis and can be life threatening. Pregnant women are more susceptible to Listeria infection, which can result in abortion. The most common way that people are affected is by consumption of contaminated food. Consumers exhibiting these signs after consuming this product should contact their healthcare provider.

The recalled JFFD Beef & Russet Potato, Fish & Sweet Potato and Turducken was distributed only through 11 JFFD retail locations in Southern California, 3 Pet Food Express (PFE) locations in Southern California and 10 Northern California PFE locations.

While testing demonstrates that only several dates of production were affected, out of an abundance of caution, JFFD is recalling all of the above mentioned products made from the dates of November 1, 2017 through January 14, 2018. These represent Best By lot code dates on all three of the JustFoodForDogs’ recalled products of 11/01/18 through 01/14/19.

The products being recalled were sold refrigerated or frozen and include all sizes offered – 7 oz, 14 oz, 18 oz and 72 oz.

No confirmed Listeriosis has been reported but there have been reports of short-term symptoms in some dogs (diarrhea and vomiting).

There have been no reports of human illness to date.

The potential for contamination was discovered after a purchaser of JFFD products reported to JFFD veterinary medical staff that her dogs had become ill. Tests to date confirm that green beans purchased from a restaurant supply distributor were positive for Listeria monocytogenes.

The restaurant supplier/distributor of these green beans has voluntarily put a “product hold” on the distribution of these green beans to restaurants and other human food retailers.

JFFD is currently making these recipes available without green beans until the matter is resolved.

JFFD notified and is working with FDA on this matter.

Consumers who have purchased the recalled JFFD products from a JFFD store should contact JFFD at 866-726-9509, from 9:00 AM – 7:00PM PST seven days a week, for a full credit or refund. Consumers who have purchased the recalled products from Pet Food Express should return them to any Pet Food Express for a full credit or refund.