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

FDA/USDA ~~ Feb 2018 Alerts & Safety pg6


  • Northwest Naturals of Portland, Oregon is recalling 5lb frozen Chicken and Salmon petfood chubs because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.Product was 1 isolated batch of 94 cases distributed to distributors in California, Washington, Texas, Michigan, Georgia, and Rhode Island and sold thru specialty pet retail stores.Product is packaged in 5lb frozen chubs labeled Chicken and Salmon Dog Food with a UPC code of 0 87316 38440 6 and a product best buy date code of 15 082218

    No pet or human illnesses have been reported to date. The product passed lab testing on 12-22-2016 and was sold over 1 year ago to distributors listed above, on or before 1-23-2017. Reports from distributors indicate there is no product at any distributors.

    The company was notified on 2-21-2018 by FDA and the Michigan Department of Agriculture and Rural Development (MDARD). MDARD bought 1 chub at a Michigan specialty pet store and tested the sample which was negative for e coli, salmonella, and positive for Listeria moncytogenes. The company tests all batches of products for all pathogens in a positive release program before releasing for shipping. The company tests over 600 batches of product per week. The company is a dual jurisdiction facility regulated by USDA-FSIS every day on every shift and FDA. The company does dual lab testing several times per month matching USDA- FSIS lab samples and comparing results.

    Consumers are encouraged to check the lot code on any 5lb frozen Chicken and Salmon chubs. Any product with the noted lot code should return product to the specialty retailer where purchased for full refund.

    Consumers with questions may contact Northwest Naturals at 1-866-637-1872, Monday-Friday, from 8:00am to 4:00pm PST or go to www.nw-naturals.net

  • TruPet, LLC of Milford, OH, is voluntarily recalling a limited amount of Treat Me Crunchy Beef Delight, 2.5oz Pet treats because the products have the potential to be contaminated with Salmonella. The recall includes only the product listed below.The following affected “Treat Me Crunchy Beef Delight” products were distributed in the continental USA via online retailer Chewy.com and TruDog.com through direct delivery:

    Affected product can be identified by comparing the following lot number: “Treat Me Crunchy Beef Delight” with “Lot # 20190514 13753”.

    No products other than the specific product identified above are subject to this voluntary recall. Consumers who have purchased Treat Me Crunchy Beef Delight are urged to return effected product to the place of purchase for a refund. Consumers with questions may call the company at 800-476-8808 for additional information.

  • Bella All Natural is voluntarily recalling its Diet Capsules labeled as Bella, Lot Number MFD:10.15.2017 EXP: 10.14.2019, to the consumer level.This recall has been initiated due to presence of sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to safety concerns. N-Desmethyl sibutramine is an active metabolite of sibutramine. Sibutramine and its active metabolites substantially increase blood pressure and/or pulse rate in some patients and may present significant health risks including heart attack, arrhythmia, and stroke. The company has not received any reports of adverse events or injuries.The product is used as a diet pill and is packaged in a plastic bottle, with 30 pills, and with the Lot Number MFD:10.15.2017 EXP: 10.14.2019. Bella was distributed in California via internet and retail.Bella All Natural is notifying its distributors and customers by Customer Notification/Recall Communication and is arranging for return of product of all recalled products. Consumers that have Bella Diet Capsules which is being recalled should stop using immediately and return to place of purchase.

    Consumers with questions regarding this recall can contact Bella all Natural by calling (323)552-6263, or e-mail address: cabral_daisy@yahoo.com on Monday-Sunday, 10 a.m. – 5:30 p.m., PST. 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 Administratio

  • Hospira, Inc., a Pfizer company, is voluntarily recalling 3 lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial (NDC 0409-2267-20), and one lot of Labetalol Hydrochloride Injection, USP, Novaplus® (NDC 0409-2267-25) to the hospital/institution level. Hospira, Inc. initiated this recall due to the discovery of cracks on the rim surface of vials for these lots, which is covered by the stopper and crimp seal.Cracked vials may result in a lack of sterility assurance for the product. Use of or exposure to a non-sterile product may be associated with adverse events such as fever, chills, sepsis or invasive systemic infections in patients. To date, Hospira, Inc. has not received any reports of adverse events associated with this issue for these lots.Labetalol Hydrochloride is an adrenergic receptor blocking agent indicated for the control of blood pressure (BP) in severe hypertension. It is administered by repeated intravenous (IV) injections or by slow IV infusion.

    Labetalol Hydrochloride Injection is packaged in a 20 mL Multiple Dose Fliptop Vial; packaged in 50 cartons per case. The affected lots include the following NDC, lot numbers, and expiry dates. For cartons, the NDC is located on the top and front label and Lot and Expiry Date information is located on the bottom.  For individual vials, the NDC, Lot and Expiry Date information is located on the vial label.

    Product was distributed nationwide to wholesalers / retailers / hospitals in the United States and Puerto Rico from April 2017 to August 2017.

    NDC Lot Number Expiration Date Strength Configuration/Count

    0409-2267-20

    74370DD
    75035DD
    75115DD

    1FEB2019
    1MAR2019
    1MAR2019

    100 mg/20 mL
    (5 mg/mL)

    1-20 mL Multiple Dose Fliptop Vial per carton; 50 cartons per case

    0409-2267-25 (Novaplus®)

    74230DD

    1FEB2019

    100 mg/20 mL
    (5 mg/mL)

    1-20 mL Multiple Dose Fliptop Vial per carton; 50 cartons per case

    Hospira, Inc. places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process.

    Hospira, Inc. has notified wholesalers/retailers/hospitals by recall letter to arrange for return of any recalled product.

    Wholesalers/retailers/hospitals/institutions with an existing inventory of the lots subject to this recall should stop use and distribution of the remaining units and quarantine immediately. Healthcare Professionals in your organization should be informed of this recall. If you have further distributed the recalled product, to the wholesale or retail level, please notify any accounts or additional locations which may have received the recalled product from you. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

    Retailers/ Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information.

    Contact Contact Information Areas of Support
    Pfizer Medical

    Information

    		 1- 800-615-0187 , option 3

    (8am to 7pm ET Monday through Friday)

    		 Medical inquiries
    Pfizer Safety 1-800-438-1985, option 1 (24 hours a day 7 days per week) To report adverse events or product complaints

    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 executed with the knowledge of the U.S. Food and Drug Administration.

  • Night Hawk Frozen Foods, Inc. Recalls Frozen Beef Products Due to Misbranding and Undeclared Allergens Night Hawk Frozen Foods, Inc., a Buda, Texas establishment, is recalling approximately 167 pounds of frozen beef patty and gravy products due to misbranding and undeclared allergens.
  • A & A Finest Recalls Frozen Pork and Shrimp Dumpling Products due to Misbranding and an Undeclared Allergen A & A Finest, a Corona, N.Y. establishment, is recalling approximately 572 pounds of frozen pork and shrimp dumpling products due to misbranding and an undeclared allergen.
  • Triple T Specialty Meats Inc. Recalls Chicken Salad Products Due to Possible Salmonella Contamination Triple T Specialty Meats, Inc., an Ackley, Iowa establishment, is recalling approximately 20,630 pounds ofready-to-eat chicken salad products that may be contaminated with Salmonella Typhimurium.
  • Updated information is now available. A list of retail consignees has been posted for recall 010-2018, Saker ShopRites, Inc. Recalls Empanadas due to Misbranding and an Undeclared Allergen (Feb 14, 2018).Saker ShopRites, Inc. Recalls Empanadas due to Misbranding and an Undeclared Allergen
    Saker ShopRites, Inc., a Linden, N.J. establishment, is recalling approximately 19,757 pounds of pork and chicken empanadas due to misbranding  and an undeclared allergen.
  • FSIS Issues Public Health Alert For Poultry Products due to Possible Salmonella Contamination
    The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert out of an abundance of caution due to concerns about illnesses reported in the state of Iowa that may be caused by Salmonellaassociated with a chicken salad product. This product was sold at all Fareway grocery stores in Iowa, as well as Illinois, Minnesota, Nebraska and South Dakota.
  • Pilgrim’s Pride Corporation Recalls Ready-to-Eat Chicken Products due to Possible Foreign Matter Contamination
    Pilgrim’s Pride Corp., a Waco, Texas establishment, is recalling approximately 101,310 pounds of ready-to-eat breaded chicken patties that may be contaminated with extraneous materials, specifically rubber.
  • The FDA is alerting pet owners to a history of four recalls of and multiple complaints associated with Darwin’s Natural and Zoo Logics pet foods, manufactured by Arrow Reliance Inc., dba Darwin’s Natural Pet Products, over the period from October 17, 2016 to February 10, 2018. In each instance, the company recalled these products after being alerted to positive findings of Salmonella and/or Listeria monocytogenes in samples of their raw pet food products. In its most recent recall, on February 10, 2018, Arrow Reliance/Darwin’s Natural recalled ZooLogics Duck with Vegetable Meals for Dogs (Lot #41957) and ZooLogics Chicken with Vegetable Meals for Dogs (Lot #41567) because the products may be contaminated with Salmonella and therefore have the potential to cause salmonellosis in humans and animals. The company states that it only sells its products online through direct-to-consumer sales. The FDA has investigated six complaints of illness and death in animals that have eaten the recalled products. Arrow Reliance/Darwin’s Natural has notified its customers directly of the recalls, but has so far not issued any public notification announcing this or any of the previous recalls.This issue is of particular public health importance because Salmonella can make both people and animals sick.ince 2016, Arrow Reliance/Darwin’s Natural has recalled the following raw pet food products: