FDA/USDA ~January Alerts & Safety


 

As a precautionary measure, T. Marzetti Company is voluntarily recalling all “Best By” dates of the following products that were distributed in Alabama, Florida, Georgia, Indiana, Kentucky, Louisiana, North Carolina, Pennsylvania, South Carolina, Tennessee, Texas, and Virginia, because they may have the potential to be contaminated with Listeria monocytogenesListeria 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.

Consumers should not consume these products.  No illnesses have been reported in connection with the recalled items

Although these products are not ready-to-eat items and have baking instructions which, if followed, will reduce consumer risk, there remains some risk that the mishandling of this product prior to or without adequate baking may cause illness.

We are working in coordination with the Food and Drug Administration (FDA) and our supplier on this recall.

All affected distributors and retail customers are being notified and the affected products are being removed from store shelves.

Affected product should be destroyed or may be returned to the place of purchase for a full refund. Consumers with questions may contact 1-866-837-2758 between 8 a.m. and 5 p.m. Eastern Time.

  • Updated information is now available. The list of retail consignees has been posted for recalls: 123-2017, Trafon Group Recalls Chicken and Pork Products Produced Without Benefit of Import Inspection (Nov 16, 2017)
  • Evershing International Trading Company is recalling 16 ounces Coconut Tree Brand Frozen Shredded Coconut because they have the potential to 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 system. 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 in to the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. No illnesses have been reported to date.This coconut products were distributed in Ohio, Massachusetts, Washington, California, Oklahoma, Illinois, Michigan, New Jersey and New York. This Frozen Shredded Coconut product is package in 16 ounces plastic bags. This recall is limited to Lot SE07A1, but the lot number is only printed on the case. Therefore, any customer that purchased this product from January 3, 2017 through January 3, 2018, should return the product to place of purchase for full refund. Customers may also contact Evershing International Trading Company at (408) 975-9660 during hours of operation, Monday to Saturday from 9:00 am to 5:00 pm.

    The issue was discovered by testing performed by the State of Massachusetts.

    This voluntary recall is being made with the knowledge of the US Food and Drug Administration. We appreciate your assistance in this matte. Although these products are not ready-to-eat items and have baking instructions which, if followed, will reduce consumer risk, there remains some risk that the mishandling of this product prior to or without adequate baking may cause illness.

    We are working in coordination with the Food and Drug Administration (FDA) and our supplier on this recall.

    All affected distributors and retail customers are being notified and the affected products are being removed from store shelves.

    Affected product should be destroyed or may be returned to the place of purchase for a full refund. Consumers with questions may contact 1-866-837-2758 between 8 a.m. and 5 p.m. Eastern Time.

AuroMedics Pharma LLC is voluntarily recalling lot AFO l 17001-A, Expiry date Dec 2018, of Ampicillin and Sulbactam for Injection USP, 1.5 g (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium salt) in a Single-Dose vial, to the hospital level. The product has been found to contain glass particles.

Risk Statement: 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.

The product Ampicillin and Sulbactam for Injection is used for treatment of infections due to susceptible strains of designated microorganism in skin and skin structure infections, intra­abdominal infections and gynecological infections in adults and for in treatment of skin and skin structure infection in pediatric patient one year and older. The affected Ampicillin and Sulbactam for Injection lot being recalled is AFO l 17001, EXP. December 2018. It is packaged in a carton containing 10 vials, NDC: 55150-116-20. The product can be identified as a ‘clear vial stoppered with grey rubber stopper and sealed with aluminum seals having a Royal Blue color polypropylene disc’. AuroMedics shipped the entire lot to wholesalers and/or hospitals nationwide on February 9, 2017.

To date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to the product.  Consumers with questions regarding this recall can contact AuroMedics Customer Service Monday through Friday from 9:00AM to 5:00PM EST at 888-238-7880 Option 1. If you need assistance in returning your product or have questions about the recall process, contact Inmar at 800-967-5952, Monday through Friday from 8:30 AM to 5:00 PM EST. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

  • ISSUE: The Agilis Steerable Introducer Sheath’s hemostatic valve, which prevents blood from flowing back through the valve, may fail due to an improper seal of the sheath hub. Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system (air embolism).
    • Model numbers and lot numbers: STJ408309, STJ408310, STJG408324; All product lots
    • Manufacturing and Distribution Dates: January 1, 2017 to May 5, 2017

    The use of affected products may cause serious health consequences for patients, including death.

    BACKGROUND: The Agilis Steerable Introducer Sheath is used to insert and position various cardiovascular catheters in the heart, including on the left side of the heart through the wall of tissue that separates the right and left chambers of the heart (interatrial septum).

    The improper seal occurs when not enough glue is used to reattach the cap to the hub after reprocessing. Too much glue can also block the sheath valve and make the device unusable.

    RECOMMENDATION: Sterilmed has provided the following instructions for health care facilities and providers:

    • Examine inventory immediately to determine if you have this product.
    • Do not use any of the affected products, and return any unused product to the company.
    • Share this information with the appropriate staff at your facility.
    • Continue to monitor patients treated with the Sterilmed Reprocessed Agilis Steerable Introducer Sheath as normal.

    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

Why is catherine running as a Democrat? #staywoke


 Ruben got an opponent,Catherine Miranda   Here’s the part you won’t believe, she’s running as a Democrat

  • She endorsed Republicans Doug Ducey for Governor and Michele Reagan for Secretary of State

Ruben is eager to have an opportunity to demonstrate the difference between a progressive fighting for working people and an anti-choice, corporate-sponsored politician who endorsed Ducey and stood by while he gutted public education.

But to do that, we need to rally support behind him right now.

We’re ready for this fight.

We know you’re with us,

— GallegoforArizona.com

do as i say … Not as i do Politics ~Think Progress


CREDIT: AP Photo/ Jacquelyn Martin

 President Donald Trump rolled out a new immigration policy that will crack down on legal immigration — limiting the amount of green cards issued in a year.

That’s really bad news for people who sell these “golden visas,” people like Trump son-in-law Jared Kushner.

– We all need to be reminded that trumpINC hires and puts in legal requests for #foreignworkers at maralago

-Nativegrl77

first posted 8/2017