FDA 2018

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FDA 2018

Postby ajsuff » Tue Mar 20, 2018 11:17 am

........................... from the FDA ............................

Bayer Issues Voluntary Recall of Alka-Seltzer Plus® Products

Bayer is voluntarily recalling Alka-Seltzer Plus® packages that:

Were sold only in the U.S. at Walmart, CVS, Walgreens and Kroger (including Dillons Food Stores, Fred Meyer, Fry’s Food Stores, Ralphs, King Soopers and Smith’s Food and Drug) after February 9, 2018. Can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall (please see attached photos). The affected packages are being recalled because the ingredients on the front sticker may not match the actual product in the carton.

The ingredients listed on the front sticker of the carton may potentially be different from the ingredients listed on the back of the carton. This may lead consumers to ingest a product to which they may have an allergy or anaphylactic reaction, an ingredient which may be contraindicated for their medical condition or they intend to otherwise avoid. There may be potential for serious health consequences.


https://www.fda.gov/Safety/Recalls/ucm6 ... rce=Eloqua
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Re: FDA 2018

Postby ajsuff » Tue Mar 20, 2018 11:31 am

.......................... from the FDA ............................

River Valley Sprouts Recalls Alfalfa Sprouts and Garlic Alfalfa Sprouts Due to Possible Salmonella Contamination

River Valley Sprouts is voluntarily recalling its 5 ounce Alfalfa Sprouts, 4 ounce Alfalfa Sprouts, 5 ounce Garlic/Alfalfa and 5 ounce Variety sprouts because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail, elderly people, and others with weakened immune systems. Healthy persons often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with salmonella can result in the organism getting into the bloodstream and producing more severe illness such as arterial infections, endocarditis and arthritis.

The recalled sprouts were packed and shipped from March 6-March 15. The sprouts were distributed in Minnesota and Wisconsin and were sold through various grocery stores. Some packages have sell by dates on the label. March 15-March 25.

The product is packaged in a plastic cup or clam container. No illnesses have been reported to date in connection with this problem.


(The recalled sprouts were packed and shipped from March 6-March 15. The sprouts were distributed in Minnesota and Wisconsin and were sold through various grocery stores.)

https://www.fda.gov/Safety/Recalls/ucm6 ... rce=Eloqua

(If you enjoy sprouts in sandwiches and salads, you should grow your own. They are quite easy and you can buy organic non-GMO seeds on line. We have had several instances here and around Canandaigua at various grocery stores that were pulled off the shelves. We grow our own sprouts here and have done so for over 20 years.
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Re: FDA 2018

Postby ajsuff » Tue Mar 20, 2018 11:34 am

......................... from the FDA ............................

Chris’s Cookies Recalls Chocolate Chip Cookies Due to Undeclared Peanuts

Chris’s Cookies has recalled one lot of its Trader Joe’s Chocolate Chip Cookie 12 Oz (340g) Bags (Barcode#: 0068 0752) after a report that Peanut Butter Chocolate Chip Cookies were discovered in a Chocolate Chip Cookie Bag, and therefore the product may contain undeclared peanuts. People who have an allergy to peanuts run the risk of serious or life-threatening allergic reaction if they eat this product.

The recalled product was distributed to Trader Joe’s stores in ONLY the following states: CT, DE, MA, MD, ME, NH, NJ, NY, Northern Virginia, PA, RI, VT and Washington D.C. The affected products are stickered on the side of the bag with Lot CODE: 2060 and date codes SELL BY 031218 through 031818

The recall was initiated after it was discovered that a bag labeled as Trader Joe’s Chocolate Chip Cookies instead contained Chocolate Chip Peanut Butter Cookies. While there is a warning statement on the label that the product may contain traces of peanuts, “peanuts” is not listed as an ingredient.


https://www.fda.gov/Safety/Recalls/ucm6 ... rce=Eloqua
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Re: FDA 2018

Postby ajsuff » Tue Mar 20, 2018 11:38 am

......................... from the FDA ............................

Oregon Food Bank Voluntarily Recalls Pumpkin Seeds Because Of Possible Contamination By Listeria Species

As a result of the ongoing recall of donated chia seeds that began on March 12, 2018, Oregon Food Bank has initiated a voluntary recall of 63,825 pounds of pumpkin seeds received on the same donation. These donated pumpkin seeds have the potential to be contaminated with Listeria species. While no illnesses have been reported we are recalling this product out of an abundance of caution.

The pumpkin seeds were distributed in Oregon and Clark County, Washington through the Oregon Food Bank Network of regional food banks and participating food pantries. The product was distributed in one pound plastic poly film bags with a twist-type closure or a re-sealable pouch or a KALE JOY plastic bag. All pumpkin seeds were distributed between November 1, 2017 and March 16, 2018. See attached images for ease of identification.

Listeria species can include 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.



https://www.fda.gov/Safety/Recalls/ucm6 ... rce=Eloqua
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Re: FDA 2018

Postby ajsuff » Tue Mar 20, 2018 11:43 am

........................ from the FDA ............................

Natural Grocers Issues Recall on Coconut Smiles Organic Due to Salmonella

Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand 10-ounce Coconut Smiles Organic due to 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 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 recalled product is packaged in clear plastic bags weighing 10 ounces and bears the “Natural Grocers” label. All packages with packed-on dates prior to 18-075 are subject to recall. The packed-on date can be found in the bottom left-hand corner of the label.


(The recalled product was distributed to 145 Natural Grocers stores located in Arkansas, Arizona, Colorado, Iowa, Idaho, Kansas, Minnesota, Missouri, Montana, Nebraska, Nevada, New Mexico, North Dakota, Oklahoma, Oregon, Texas, Utah, Washington and Wyoming.)


https://www.fda.gov/Safety/Recalls/ucm6 ... rce=Eloqua
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Re: FDA 2018

Postby ajsuff » Wed Mar 28, 2018 9:44 am

....................... from the FDA ............................

FDA Alerts Pet Owners about the Presence of Thyroid Hormones in Certain Milo’s Kitchen Pet Treats

The FDA is alerting pet owners and veterinary professionals about the recall of certain Milo’s Kitchen pet treats after FDA testing found thyroid hormones in products eaten by four dogs that showed symptoms of hyperthyroidism, a disease that is rare in dogs.

The FDA’s evaluation of the test results of Milo’s Kitchen treat samples indicates that the treats contain thyroid hormones in substantial amounts. Consuming these treats can trigger hyperthyroidism in dogs. Hyperthyroidism caused by pet food or treats is generally reversible if the dog stops eating the product containing thyroid hormones, but prolonged consumption may result in permanent heart damage and death.


Read entire article.
https://www.fda.gov/AnimalVeterinary/Ne ... rce=Eloqua

More Animal Health Topics
https://www.fda.gov/AnimalVeterinary/de ... rce=Eloqua
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Re: FDA 2018

Postby ajsuff » Thu Mar 29, 2018 8:40 am

.......................... from the FDA ............................

Mrs. Gerry’s Kitchen Issues Allergen Alert on Undeclared Seafood in Salad

Mrs. Gerry’s Kitchen Inc. of Albert Lea, MN is issuing a voluntary recall of the following items.

The salads may contain undeclared traces of imitation crab meat. People who have allergies to fish or shell fish run the risk of serious or life-threatening allergic reaction if they consume these products. The recalled salad was shipped to retail and food service distributors in IL, IA, KS, MI, MN, MT, NE, ND, SD, UT, and WI. No illnesses have been reported to date in connection with this problem.

Mrs. Gerry’s takes the safety and quality of our products very seriously. Customers or consumers who have purchased any of these items are urged to discard the products or return them to the place of purchase for a full refund. Consumers with questions may contact Customer Service at Mrs. Gerry’s Kitchen, Inc. at 1-800-642-9662.


https://www.fda.gov/Safety/Recalls/ucm6 ... rce=Eloqua
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Re: FDA 2018

Postby ajsuff » Thu Mar 29, 2018 8:43 am

.......................... from the FDA ............................

Blue Ridge Beef Voluntarily Recalls BRB Complete Raw Pet Food Lot#GA0131 Because of Possible Contamination

Blue Ridge Beef of Eatonton, GA, is voluntarily recalling lot#GA0131 of BRB Complete raw pet food because of the potential of contamination with Salmonellaand Listeria monocytogenes.

The cause of the recall:
This recall was initiated after samples collected and tested by the FDA showed positive for Salmonella and Listeria monocytogenes. There has been no consumer or pet illnesses in association with this product. Blue Ridge Beef is voluntarily recalling this product lot as a commitment to consumer and pet health and safety.


The recalled lot would affect the following states: Florida, Georgia, South Carolina, Tennessee
North Carolina


https://www.fda.gov/Safety/Recalls/ucm6 ... rce=Eloqua
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Re: FDA 2018

Postby ajsuff » Thu Mar 29, 2018 8:48 am

.......................... from the FDA ............................

Darwin’s Natural Pet Products Issues Voluntary Recalls for Darwin’s Brand Dog Foods Due To Contamination Salmonella And Shiga Toxin-Producing Escherichia Coli O128

Darwin’s Natural Pet Products of Tukwila, Wash., a manufacturer of fresh raw meals for dogs, today announced it is voluntarily recalling a total of four lots of products after testing showed that some of the Chicken and Duck with Organic Vegetables Meals for Dogs may contain Salmonella, and the Turkey with Organic Vegetables Meals for Dogs sample may contain Salmonella and E. coli O128. These pathogens can cause serious and sometimes fatal infections.

Darwin’s Natural Pet Products are exclusively sold to customers through a subscription service. Customers who purchased the products have been notified of the recall directly by Darwin’s.



https://www.fda.gov/Safety/Recalls/ucm6 ... ignId=2187
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Re: FDA 2018

Postby ajsuff » Thu Mar 29, 2018 8:50 am

......................... from the FDA ............................

Allergy Alert Issued in Select Northern California Whole Foods Market Stores for Undeclared Egg in Some Cookies

Nine Whole Foods Market stores in Northern California are voluntarily recalling some decorated (iced) cookies from the self-service cookie displays because the products contained egg allergen that was not listed on the product sign. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

All affected products have been removed from store shelves. The affected cookies are iced in the shape of eggs, bunnies or chicks and were available unwrapped in the self-service bulk cookie displays. The products were sold on or before March 25th, 2018. One illness has been reported to date.



https://www.fda.gov/Safety/Recalls/ucm6 ... rce=Eloqua
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Re: FDA 2018

Postby ajsuff » Thu Mar 29, 2018 8:52 am

......................... from the FDA ............................

eBars Issues Allergy Alert on Undeclared Allergens

eBars LLC of Franklin, Tenn. is issuing a voluntary recall on its line of products that may contain undeclared peanut and/or almond allergens.

The “Use By” dates showing between June 21, 2017 through July 18, 2018 including: MAN, WOMAN, TRIM Cocoa Raspberry, TRIM Cocoa Almond, RUN Cocoa Almond, RUN Cocoa Raspberry, FOCUS Chocolate Peanut, FOCUS 4 KIDS, GOLF Chocolate Almond, GOLF Cocoa Raspberry, HEAL Chocolate Peanut, FIT Organic Peanut Butter Chocolate Raspberry.

No illnesses, reactions or events have been reported to date.


The bars listed above were distributed through Whole Foods in Tennessee, Alabama, Mississippi, North Carolina, South Carolina, and Georgia, and through Kroger in Virginia, North Carolina, South Carolina, Mississippi, Texas, West Virginia, Michigan, Indiana, Tennessee, Alabama, Kentucky, Ohio, and Georgia. They were also distributed nationwide through ebars.com website.

https://www.fda.gov/Safety/Recalls/ucm6 ... rce=Eloqua
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Re: FDA 2018

Postby ajsuff » Thu Mar 29, 2018 8:55 am

........................ from the FDA ............................

First Source Issues Allergy Alert on Undeclared Peanuts in Wegmans 9 Oz Yogurt Raisins

First Source of Tonawanda, NY, is voluntarily recalling 9 OZ packages of Wegmans Yogurt Raisins, because the product may contain undeclared peanuts. People who have an allergy or sensitivity to peanuts run the risk of serious or life- threatening allergic reaction if they consume this product.

The recalled retail packaged item is as follows:
Wegmans Yogurt Raisin 9 OZ (255g), in a plastic tub, UPC: 0 77890 31832 4, with BEST BEFORE 01/05/19

These products were distributed at Wegmans Stores in the following states MA, MD, NJ, NY, PA, and VA, The affected product was sold from January 16, 2018 to present.

No illnesses or allergic reactions have been reported to date.


These products were distributed at Wegmans Stores in the following states MA, MD, NJ, NY, PA, and VA, The affected product was sold from January 16, 2018 to present.

https://www.fda.gov/Safety/Recalls/ucm6 ... rce=Eloqua
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Re: FDA 2018

Postby ajsuff » Fri Apr 06, 2018 8:48 am

.......................... from the FDA ............................

FDA has recently approved the following devices to be marketed:

Lifeline/ReviveR ECG and DDU Automated Defibrillators - P160032
The LifeLine/ReviveR Public Access Defibrillators (PAD) family of Automated External Defibrillators (AEDs) are portable, battery operated, defibrillators intended to deliver lifesaving electrical shocks to people experiencing sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating.

https://www.fda.gov/MedicalDevices/Prod ... ignId=2267

Abbott Perclose ProGlide Suture-Mediated Closure System - P960043/S097
The Perclose ProGlide Suture-Mediated Closure System is composed of a plunger, handle, guidewire, and sheath. The device is designed to deliver a single suture (stitch) to close the puncture sites (access sites) in large vessels in the leg (femoral vein or artery) following catheterization procedures. Catheterization procedures are commonly used to observe or treat a disease/condition in blood vessels or in the heart. During these procedures, an opening may be made in the femoral vein or artery to insert a catheter (flexible tube). After the procedure is finished, the catheter is removed. The placement of a suture where the catheter was inserted will prevent blood flow until the access site heals.

https://www.fda.gov/MedicalDevices/Prod ... ignId=2267
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Re: FDA 2018

Postby ajsuff » Wed Apr 18, 2018 8:31 am

......................... from the FDA ............................

World’s Best Cheese Recalls l’Explorateur Soft Ripened Cheese Due to Possible Health Risk

World’s Best Cheeses of Armonk, NY is recalling 22 cases of Formagerie de la Brie brand, l’Explorateur soft ripened cheese because it has 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.

The Formagerie de la Brie brand, l’Explorateur, soft ripened cheese made from pasteurized milk was distributed in NY, NJ, CT, MD, UT, CO, SC, PA, TX and Washington D.C. through retail stores beginning February 28, 2018 through April 13, 2018. The Explorateur product comes in a 250g (8.8 oz.), clear plastic package marked with lot #’s H036, H038, H043 and H044.


https://www.fda.gov/Safety/Recalls/ucm6 ... rce=Eloqua
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Re: FDA 2018

Postby ajsuff » Wed Apr 18, 2018 8:41 am

......................... from the FDA ............................

FDA has recently approved the GORE® CARDIOFORM Septal Occluder to be marketed.

The GORE CARDIOFORM Septal Occluder is a device that is permanently implanted in the heart to close a patent foramen ovale (PFO). A PFO occurs when the foramen ovale, a naturally occurring hole located between the two upper chambers of the heart (the right atrium and the left atrium), does not close shortly after birth. If untreated, a PFO can allow a small amount of blood to pass from the right side of the heart to the left side of the heart. In rare cases, a PFO may lead to the occurrence of strokes.

The device includes an implant (occluder) and a delivery catheter (a small tube). The occluder is made of self-expanding, nickel-titanium (Nitinol) wires, covered in woven fabric. The occluder is shaped as two discs connected in the center. The occluder is compressed to a small size to allow it to pass through the delivery catheter so that physicians can implant it within the heart.


https://www.fda.gov/MedicalDevices/Prod ... ignId=2406
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Re: FDA 2018

Postby ajsuff » Wed Apr 18, 2018 9:00 am

.......................... from the FDA ............................

Battery Performance Alert and Cybersecurity Firmware Updates for Certain Abbott (formerly St. Jude Medical) Implantable Cardiac Devices: FDA Safety Communication

On April 11, 2018, the FDA approved a firmware update that is now available and is intended as a corrective action (recall), to reduce the risk of patient harm due to premature battery depletion and potential exploitation of cybersecurity vulnerabilities for certain Abbott ICDs and CRT-Ds. "Firmware" is a specific type of software embedded in the hardware of a medical device (e.g. a component in the defibrillator).

The FDA recommends that all eligible patients receive the firmware update at their next regularly scheduled visit or when appropriate depending on the preferences of the patient and physician.

For the purposes of this safety communication, cybersecurity focuses on protecting patients' medical devices and their associated computers, networks, programs, and data from unintended or unauthorized threats.

This firmware update includes mitigations to addresses two separate issues: 1) a device-based Battery Performance Alert to detect rapid battery depletion in devices subject to the Battery Advisory from October 2016; and 2) updates to address cybersecurity vulnerabilities across Abbott's radio frequency (RF) enabled ICDs and CRT-Ds



https://www.fda.gov/MedicalDevices/Safe ... ignId=2407
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