~ FDA/USDA ~~ Alerts & Safety, ~ politics petitions pollution and pop culture

FDA/USDA ~ Dec Alerts & Safety pg2


  •  Updated information is now available. A list of retail consignees has been posted for recall 131-2017, Swift Beef Company Recalls Beef Stew Products Due to Possible Foreign Matter Contamination (Dec 26, 2017).     Swift Beef Company Recalls Beef Stew Products Due to Possible Foreign Matter Contamination Swift Beef Co., doing business as JBS USA Food Company, a Cactus, Texas establishment, is recalling approximately 4,702 pounds of beef stew product that may be contaminated with foreign matter , specifically plastic and metal.
  • AuroMedics Pharma LLC is voluntarily recalling one lot of Linezolid Injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007 expiration August 2018 to the hospital level. This batch was distributed May 15 through August 14, 2017. The product was found to contain white particulate matter that has been identified as mold. This problem was discovered as a result of a product complaint in which the contents of one flexible bag from one batch CLZ160007 was found to contain white particulate matter.

    Use of a non-sterile injectable product could result in fatal infections in a broad array of patients. To date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to this recall.
  • Nodine’s Smokehouse, Inc. of Torrington, Connecticut is recalling Smoked Salmon 1.5 lbs, 8 oz packages. Lot numbers 40173 and 33173 because they have the potential to be contaminated with Listeria monocytogenes. Consumption of food contaminated with Listeria monocytogenes can cause listeriosis, with high fever, severe headache, neck stiffness, and nausea as its primary symptoms. In rare cases, listeriosis is fatal; it can also cause miscarriages and stillbirths. People experiencing these problems should seek immediate medical attention. Pregnant women the very young, elderly, and persons with compromised immune systems are
    the most susceptible.The Smoked Salmon was distributed nationwide in retail stores and through mail orders. The product comes in 1.5 lb and 8 oz packages with lot numbers 40173 and 33173.
  • PFP Enterprises LLC Recalls Ground Beef Products Due to Misbranding and An Undeclared AllergenPFP Enterprises LLC, also doing business as Texas Meat Packers, a Fort Worth, Texas establishment, is recalling approximately 7,570 pounds of ground beef products due to misbranding and an undeclared allergen.
  • As a result of the Fresh-Pak Inc. recall, Meijer is announcing a voluntary recall of select Meijer brand packaged products due to sliced apples within the products being potentially contaminated with Listeria monocytogenes. To date, there have been no known illnesses reported in connection with this recall.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, including animals. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, a Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women.The following Meijer brand packaged products contain apple slices that were supplied by Detroit-based Fresh-Pak, Inc. Meijer received notice of a possible Listeria monocytogenes contamination from Fresh-Pak, which was alerted by their supplier, Jack Brown. The recalled product will be in plastic containers with printed labels and include “sell by” range of December 17, 2017 through December 21, 2017.    The products were sold in Meijer stores in Michigan, Ohio, Indiana, Illinois, Kentucky and Wisconsin.  Customers should stop using the product and either dispose of it, or return it to the customer service desk at any Meijer store for a full refund. For additional information, please contact Meijer at (800) 543-3704, available 24 hours a day, seven days a week. Meijer stores are opened 24 hours a day, seven days a week.
  • East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial, to the hospital level. The product was found to contain glass particles in the vial.  This problem was discovered as a result of a product complaint in which the contents of one vial from one batch was found to contain a piece of glass.The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening. To date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to this recall.Pantoprazole Sodium for Injection 40 mg per vial, is used for short term treatment of gastroesophageal reflux disease associated with a history of erosive esophagitis and pathological hypersecretion including zollinger-ellison syndrome and is packaged in a carton containing 10 vials, NDC: 55150-202-10. The affected Pantoprazole Sodium for Injection lot being recalled is CPO170035, EXP. May 2019. The product can be identified as ‘vial stoppered with grey slotted rubber stopper and sealed with aluminum seals having Sky Blue color polypropylene disc’. AuroMedics commenced shipping the product to customers on August 7, 2017 and was distributed to wholesalers and/or hospitals nationwide.AuroMedics Pharma LLC is notifying its distributors and customers by recall letters and is arranging for return/replacement etc. of all recalled product. Consumers/distributors/retailers that have the product lot which is being recalled should immediately stop using and return to place of purchase/contact their doctor as appropriate.Consumers with questions regarding this recall can contact Aurobindo Customer Service weekdays 9:00AM to 5:00PM EST at 866-850-2876 Option 1.  If you need assistance in returning your product or have questions about the recall process, contact Inmar at 800-967-5952 weekdays Monday through Friday 8:30 AM to 5:00 PM EST. 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.

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

  • Springfield Smoked Fish of Springfield, MA is expanding their voluntary recall of smoked fish products 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, Listeriainfection can cause miscarriages and stillbirths among pregnant women.Recalled products were distributed and sold at retail stores and wholesale establishments in Massachusetts, Connecticut, New York, Rhode Island, Colorado, Ohio, Pennsylvania from May 2017 through December 2017. Product was also sold nationwide through online sales.The initial recall was limited to 1lb pre-sliced Nova Salmon produced on 11/24/17. The recall expansion includes product produced between May 22, 2017 and December 12, 2017, the date the facility ceased production of the products.These products were sold under the brand names Springfield Smoked Fish and Rachael’s Springfield Smoked Fish.No illnesses have been reported to date in connection with this problem.The recall expansion was initiated as a result of environmental and product sampling conducted by the firm. Springfield Smoked Fish is committed to ensuring consumer safety and providing quality products and ingredients to customers.  The company is working diligently to determine the root cause and continues working with food safety experts to implement corrective actions and preventative measures.Retailers and wholesale customers should check their inventories and shelves to confirm that none of the recalled products are present or available for purchase by consumers or in warehouse inventories.  Please contact Springfield Smoked Fish for disposal or return of the product.Consumers are urged not to consume these products. Consumers who purchased these products may take them back to the store where they purchased them for a refund or simply discard them. Consumers with questions may contact the company at 1-413-737-8693, Monday through Friday 8:00 am – 4:00 pm.