• Jack Brown Produce, Inc. of Sparta, MI is recalling Gala, Fuji, Honeycrisp and Golden Delicious apples processed and shipped by one of its suppliers, Nyblad Orchards, Inc., on December 11 through December 16, 2017, 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. No illnesses have been reported to date.

  The recalled apples were distributed through retail stores in Michigan, Georgia, Missouri, Indiana and Ohio. The product at issue consists of the following types of apples sold or distributed by Jack Brown Produce, Inc. under the brand name “Apple Ridge” including:

  1. Honeycrisp apples in two-pound clear plastic bags;
  2. Gala, Fuji, and Golden Delicious apples in 3-pound clear plastic bags;
  3. Fuji and Gala apples in 5-pound red-netted mesh bags; and
  4. Gala, Fuji and Honeycrisp apples that were tray-packed/individually sold.

  The potentially-affected product can be identified by the following lot numbers printed on the bag label and/or bag-closure clip:

  Fuji: NOI 163, 165, 167, 169, 174

  Honeycrisp: NOI 159, 160, 173 Golden Delicious: NOI 168
  Gala: NOI 164, 166 on either the product labels and/or bag-closure clip.

  The recall was the result of a routine sampling program at the Nyblad Orchards, Inc. facility which revealed that finished products contained Listeria monocytogenes. Jack Brown Produce, Inc. has ceased the distribution of any further products processed at Nyblad Orchards as the FDA and the Company continue their investigation as to what caused the problem.

  Consumers who have purchased Gala, Fuji, Honeycrisp and Golden Delicious Apples under the brand name “Apple Ridge” on or after December 11, 2017 are urged to destroy the product and contact Jack Brown Produce, Inc. for a full refund.

  Consumers with questions may contact the company at 616-887-9568 (Monday-Friday, 8:00 a.m. to 5:00 p.m. ET) and ask for Lisa Ingalls.

• Santa Fe Importers, Inc. Recalls Ready-To-Eat Pork Products due to Possible Extraneous Material ContaminationSanta Fe Importers, Inc. a Long Beach, Calif. establishment, is recalling approximately 143 pounds of pork salami products that may be contaminated with extraneous materials, specifically metal shavings
• Products due to Possible Salmonella Adulteration Piller’s Fine Foods, a Waterloo, Canada establishment, is recalling approximately 1,076 pounds of ready-to-eat salami and speck products that may be adulterated with Salmonella.
• Springfield Smoked Fish of Springfield, Ma.is recalling its 1lb. packages Prescliced Nova Salmon because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious 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.The recalled packages were distributed to customers in Rhode Island and Connecticut through retail stores.The product comes in a 1lb, clear plastic package marked with lot # 42173 on the back of the package and with an expiration date of 12/22/17. UPC 811907018018.No illnesses have been reported to date in connection with this problem.This issue was identified after FDA product sampling identified Listeria monocytogenes in the product.The production of the product has been suspended while FDA and the company continue to investigate the source of the problem.Consumers who have purchased the 1lb packages of the pre-sliced Nova Salmon are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-413-737-8693. Monday through Friday 8 am – 5 pm.
• December 5, a partner food pantry agency in Wamego, Kansanotified Harvesters—The Community Food Network of potentially contaminated Bibi Frutix candy product it received through Harvesters’ distribution program.The candy product is likely contaminated with a chemical substance and is potentially harmful if eaten. To date, there has been a report of one illness. The candy product is the shape of a small baby bottle and labeled “Bibi Frutix.” The product was donated to Harvesters. Harvesters estimates six cases or fewer of the candy product was received.Harvesters followed recall procedures, including issuing a recall notice to all partner agencies (food pantries) and checking to see if any product remained in its warehouses. To date, no product has been found beyond what was involved in the initially reported incident in Wamego, Kan.Harvesters’ agencies that could have received the product are located in the following 19 counties of Harvesters’ service area: Kansas: Johnson, Wyandotte, Miami, Franklin, Douglas, Jefferson, Shawnee, Nemaha, Pottawatomie, and Wabaunsee. Missouri counties are:
  Jackson, Platte, Clay, Ray, Lafayette, Johnson and Bates. Harvesters continues to cooperate with local and state authorities to determine the potential scope of the distribution.This may be an isolated incident. Out of concern for public safety, Harvesters is alerting the public. The safety of the public, Harvesters’ agency partners, volunteers, clients and staff is most important.The FDA has advised, if a member of the community has possession of the candy product, do not consume the product and dispose of it immediately. People who experience symptoms should contact their health care provider for treatment. If you believe product you received was contaminated, you may file a complaint with the FDA consumer complaint coordinator for Kansas and Missouri at 1-800-202-9780.

• FDA Alerts Consumers About Potentially Life-Threatening Health Problems Linked to Limbrel

  December 4, 2017

  The U.S. Food and Drug Administration has recommended that Primus Pharmaceuticals, Scottsdale, Arizona, voluntarily recall Limbrel, a capsule marketed to “manage the metabolic processes associated with osteoarthritis.” The company has not yet acted to remove the product from the market. Although the product is marketed as a medical food, the preliminary determination of the FDA investigation is that Limbrel is an unapproved new drug. The agency does not have mandatory recall authority over drug products.

  The FDA reminds consumers not to use Limbrel because of the risk of drug-induced liver injury, and a lung condition called hypersensitivity pneumonitis. Consumers taking this product should stop immediately and contact their health care provider. Health care providers who are aware that their patients are taking Limbrel should advise them to stop using it. 

  Who Should be Contacted?

  Consumers and health care professionals who have questions about Limbrel are encouraged to contact the FDA’s Division of Drug Information at 888-INFO-FDA (888-463-6332) or druginfo@fda.hhs.gov.

  The information in this release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available.

   

• Updated information is now available. A list of retail consignees has been posted for recall 127-2017, Rafedain Shish Kabob Restaurant, Inc. Recalls Chicken Patty Shish Kabob Products Due To Misbranding and Undeclared Allergens (Dec 1, 2017).
• Simple Diagnostics is voluntarily recalling three lots of Pharmacist Choice Alcohol Prep Pads (UPC # 898302001050, NDC # 98302-0001-05), which were manufactured by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues. The affected lots are:  SD2070421201 (Exp. 12/2019)
  SD2070420925 (Exp. 09/2019)
  SD2070420601 (Exp. 12/2019)The affected lots were distributed between 10/18/2016 and 07/19/2017  : Simple Diagnostics is notifying its distributors and customers by issuing a “Dear Customer” letter and arranging for the return of all recalled products. Healthcare providers that have affected lots of Pharmacist Choice Alcohol Prep Pads that have been recalled should stop using the product and should return them to Simple Diagnostics.Health professionals and consumers with questions regarding this recall can contact Simple Diagnostics at 1-877-342-2385.Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form 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

  Read the MedWatch Safety Alert, including a link to the press release, at:
  https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm587711.htm

• The Kroger Company has recalled Comforts FOR BABY Purified Water with Fluoride Added 1 GAL (3.78 L) with sell by dates from 4/26/2018 to 10/10/2018, after receiving complaints about mold in the product. Testing by Kroger has identified the mold as Talaromyces penicillium. The water is sold in clear containers, but the mold may not be visible with the naked eye.

The FDA is issuing this consumer alert to reach parents and Consumers caregivers who may have bought the product, which is intended for infants.

 1-888-SAFEFOOD

The products were distributed to Kroger stores, including Food 4 Less, Jay C, Jay C Food Plus, Kroger, Kroger Marketplace, Owen’s, Payless Super Market, and Ruler stores in Alabama, Arkansas, Georgia, Illinois, Indiana, Kentucky, Mississippi, Missouri, North Carolina, Ohio, South Carolina, Tennessee, Virginia and West Virginia.  The Kroger Company has instructed its stores to remove the recalled products. The recalled products are labeled with the UPC Code 0 41260 37597 2 and the plant code 51-4140. The labels also state DISTRIBUTED BY THE KROGER CO, CINCINNATI, OHIO 45202. If you have purchased this water return it to the store for a refund.

•  Updated information is now available. A list of retail consignees has been posted for recall 127-2017, Rafedain Shish Kabob Restaurant, Inc. Recalls Chicken Patty Shish Kabob Products Due To Misbranding and Undeclared Allergens (Dec 1, 2017).