FDA 2017

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Re: FDA 2017

Postby ajsuff » Wed May 24, 2017 10:09 am

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

Medical Device Safety and Recalls: Abbott-Thoratec Recalls HeartMate II LVAS Pocket System Controller Due to Risk of Patient Injury and/or Death during Backup Controller Exchange

Patients may sometimes need to change to their backup back-up system controller during the course of ventricular assist therapy. The change should be done quickly and in the hospital, because it can present a significant challenge to patients that are elderly and/or untrained. For these patients, a slow or improper driveline changeover places them at risk of serious injury or death. Abbott-Thoratec has received a total of 70 reports of incidents in which the controller has malfunctioned after an exchange, including 19 injuries and 26 deaths. All of the deaths occurred when patients attempted to exchange controllers while away from the hospital. To address this issue, Abbott-Thoratec is providing all HeartMate II LVAS with Pocket Controller users with new software and hardware updates to assist patients in successfully changing their pocket controller in emergency situations.


https://www.fda.gov/MedicalDevices/Safe ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Fri May 26, 2017 10:10 am

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

California Sun Dry Foods Announces a Voluntary Recall of Mislabeled California Sun Dry Sun-Dried Tomato Pesto Due to Undeclared Almond and Milk Allergen

California Sun Dry Foods today issued a voluntary recall of California Sun Dry Sun-Dried Tomato Pesto because of a potentially incorrect back label on some jars. This mislabeling incident resulted in undeclared allergens (Almonds and Milk). People who have an allergy or severe sensitivity to tree nuts and milk run the risk of serious or life-threatening allergic reaction if they consume this product.

The product involved was distributed through retail stores nationwide


https://www.fda.gov/Safety/Recalls/ucm5 ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Sat May 27, 2017 7:31 pm

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

Recall on Fewer Than 225 Ava's Brand Organic Cashews Roasted & Salted 8 oz. Tubs in NJ, NY, PA and CT

Hampton Farms is voluntarily recalling Ava's brand Organic Cashews Roasted & Salted 8 oz. tubs distributed in New Jersey, New York, Pennsylvania and Connecticut. We have been notified by our cashew supplier that the cashews used have the potential to be contaminated with Listeria monocytogenes. No confirmed illnesses have been reported to public health authorities to date.


https://www.fda.gov/Safety/Recalls/ucm5 ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Sat May 27, 2017 7:34 pm

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

Magellan Diagnostics is recalling the LeadCare Plus and the LeadCare Ultra Testing Systems because they may underestimate the blood lead levels (BLL) and give inaccurate results when processing venous blood samples. Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning. The use of affected product may cause serious adverse health consequences.

This recall accompanies FDA's safety communication from May 17, 2017. Magellan's LeadCare Plus and Ultra Testing Systems are two of four blood lead testing systems affected by the recommendations in FDA's safety communication.

The FDA is unable to identify the root cause for the inaccurate results, based on data provided by Magellan. We are conducting studies with the Center for Disease Control and Prevention (CDC) to identify the cause and better characterize the extent of the problem.



https://www.fda.gov/MedicalDevices/Safe ... ovdelivery

https://www.fda.gov/MedicalDevices/Safe ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Thu Jun 01, 2017 1:38 pm

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

Smucker Foods of Canada Corp. Announces a Voluntary Recall on Select Golden Temple®, Swad®, and Maya® Flour Products in the U.S. Due to Possible E. Coli 0121 Contamination

In collaboration with the U.S. Food and Drug Administration (FDA), Smucker Foods of Canada Corp. today announced a voluntary recall on specific production codes of Golden Temple®, Swad®, and Maya® flour products in the U.S. due to possible E. coli O121 contamination.


https://www.fda.gov/Safety/Recalls/ucm5 ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Thu Jun 01, 2017 1:44 pm

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

Seasonal Allergies: Which Medication is Right for You?

The FDA regulates many products that treat allergies or offer allergy relief

Learn which type of products will work best to relieve your particular symptoms.
https://www.fda.gov/ForConsumers/Consum ... ovdelivery


Allergy Relief for Your Child

Do you have a sneezing, stuffy-nosed child? He or she may have allergies


Learn more about proven treatments for children.
https://www.fda.gov/ForConsumers/Consum ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Tue Jun 06, 2017 8:28 pm

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

Outsmarting Poison Ivy and Other Poisonous Plants

Poison ivy and other poisonous plants are a hazard all year. The U.S. Food and Drug Administration has some tips for preventing and treating the itchy rash and blisters. Read the Consumer Update to learn more, and watch our video to learn what poison ivy, oak, and sumac plants look like so you can avoid them.


https://www.fda.gov/ForConsumers/Consum ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Tue Jun 06, 2017 8:36 pm

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

FDA Investigates Findings of Hepatitis A Linked to Frozen Tuna

https://www.fda.gov/Safety/Recalls/ucm5 ... ovdelivery

Please find more information about the Outbreak of Hepatitis A Illnesses Linked to Raw Scallops here:

https://www.fda.gov/Food/RecallsOutbrea ... 561199.htm
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Re: FDA 2017

Postby ajsuff » Thu Jun 08, 2017 8:18 pm

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

Braces Have Changed, From Metal to Tooth-Colored to Clear

The FDA answers your questions about braces and how they've changed.


https://www.fda.gov/ForConsumers/Consum ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Thu Jun 08, 2017 8:22 pm

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

Happy Sprout Inc. Recalls Soybean Sprouts Due To Possible Health Risk

Happy Sprout Inc. of Springfield, VA is voluntarily recalling all packages of soybean sprouts because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections to individuals 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.

(These items were distributed to retail stores in Virginia, Maryland and New Jersey)

https://www.fda.gov/Safety/Recalls/ucm5 ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Mon Jun 12, 2017 11:16 am

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

United Pet Group Voluntary Recalls Multiple Brands of Rawhide Chew Products for Dogs Due to Possible Chemical Contamination

United Pet Group, a division of Spectrum Brands, Inc. is voluntarily recalling multiple brands of packages of rawhide dog chew products that were distributed to retail outlets and sold online in the U.S. The recall was initiated after United Pet Group identified that certain of its rawhide chew manufacturing facilities located in Mexico and Colombia, as well as one of its suppliers in Brazil, were using a quaternary ammonium compound mixture as a processing aid in the manufacturing of rawhide chews. The compound is an anti-microbial chemical that is approved for cleaning food processing equipment, but it has not been approved in the U.S. as a processing aid in the production of rawhide chews for do


https://www.fda.gov/Safety/Recalls/ucm5 ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Mon Jun 12, 2017 11:20 am

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

United Pet Group Voluntary Recalls Multiple Brands of Rawhide Chew Products for Dogs Due to Possible Chemical Contamination

United Pet Group, a division of Spectrum Brands, Inc. is voluntarily recalling multiple brands of packages of rawhide dog chew products that were distributed to retail outlets and sold online in the U.S. The recall involves the brands and products described b

The affected product was distributed nationwide from United Pet Group’s Edwardsville, Illinois distribution facility and was delivered to consumers through various retail establishments including online outlets

https://www.fda.gov/Safety/Recalls/ucm5 ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Tue Jun 13, 2017 3:54 pm

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

Bristol-Myers Squibb Voluntarily Recalls One Lot of Eliquis (apixaban) 5 mg Tablets

Bristol-Myers Squibb Company (NYSE: BMY) is voluntarily recalling one lot (#HN0063) of Eliquis 5 mg tablets to the consumer level. This lot was distributed nationwide in the U.S. to wholesalers and retail pharmacies in February 2017. Bristol-Myers Squibb is taking this precautionary measure based on a customer complaint that a bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets.

The recalled lot was distributed Nationwide in the U.S. to wholesalers and retail pharmacies in February 2017.


https://www.fda.gov/Safety/Recalls/ucm5 ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Thu Jun 15, 2017 10:19 am

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

Breast Cancer in Men: Treatments and Genetic Counseling

Breast cancer in men tends to be diagnosed at an older age and a later stage. This Men's Health Week, learn why all men with breast cancer need genetic testing and how the U.S. Food and Drug Administration is helping men improve their health. “For the first time, men can access investigational treatments in clinical trials and contribute to scientific advances and knowledge for others with this disease,” says Tatiana M. Prowell, MD, breast cancer scientific liaison at the FDA.

Read the Consumer Update to learn about breast cancer treatments for men.
https://www.fda.gov/ForConsumers/Consum ... ovdelivery

(My next door neighbor of mine (a cousin) was diagnosed with breast cancer (male) while he was in high school. He had it surgically removed and currently works fro a large Attorney's Firm in NJ)
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Re: FDA 2017

Postby ajsuff » Thu Jun 15, 2017 10:21 am

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

Loving Pets Voluntarily Recalls Limited Lot Numbers of Air-Puffed Dog Treats Because of Possible Salmonella Health Risk

Loving Pets of Cranbury, NJ is voluntarily recalling a limited number of dog treats because of the potential to be contaminated with Salmonella. Salmonella 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.


https://www.fda.gov/Safety/Recalls/ucm5 ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Thu Jun 15, 2017 10:23 am

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

Wildway LLC Issues Voluntary Recall of Certain Grain-Free Granola Products

Wildway LLC is voluntarily recalling certain grain-free granola codes, because the Company has been notified by an ingredient supplier that an ingredient used in these products has the potential to be contaminated with Listeria monocytogenes.


https://www.fda.gov/Safety/Recalls/ucm5 ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Sun Jun 25, 2017 9:52 pm

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

Tattoo Removal: Options and Results

How hard is it to remove a tattoo? What processes are used? Is it painful?

Get the answers from the FDA.
https://www.fda.gov/ForConsumers/Consum ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Sun Jun 25, 2017 9:57 pm

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

Recall Expansion in New Jersey on Fewer than 650 units of Ava’s Brand Organic Roasted Unsalted Cashews and Organic Roasted Unsalted Almonds

Hampton Farms is expanding its voluntary recall to include Ava’s Brand Organic Roasted Unsalted Cashews and Ava’s Brand Organic Roasted Unsalted Almonds distributed only in New Jersey. This is the result of a recall expansion from Hampton Farms’ supplier, Hudson Valley Foods, Inc. of Highland, NY advising Hampton Farms that ingredients sold to the company have the potential to be contaminated with Listeria monocytogenes.


https://www.fda.gov/Safety/Recalls/ucm5 ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Tue Jun 27, 2017 12:59 pm

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

Publix Recalls Publix Tropical Medley Mix Due to Possible Contamination with Listeria monocytogenes

Publix Super Markets is issuing a voluntary recall for Publix Tropical Medley Mix because it may be adulterated with Listeria monocytogenes. Publix received notification of the potential contamination from our supplier of dried apricot, The 5.7oz clear plastic containers of the mix were sold from Publix retail produce departments in Florida, Georgia, South Carolina, Alabama, Tennessee and North Carolina with a UPC of 41415088586. All use by dates are being recalled.


https://www.fda.gov/Safety/Recalls/ucm5 ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Tue Jun 27, 2017 1:01 pm

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

Tips to Stay Safe in the Sun: From Sunscreen to Sunglasses

Today is National Sunglasses Day. So don a pair, and learn about other ways to protect yourself from sun damage.


https://www.fda.gov/ForConsumers/Consum ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Thu Jul 27, 2017 10:35 am

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

FDA Approves First Medication for Pain Control in a Food-producing Animal

The U.S. Food and Drug Administration announces the approval of Banamine Transdermal (flunixin transdermal solution), an animal drug approved for the control of pain associated with foot rot and the control of pyrexia (fever) associated with bovine respiratory disease.


https://www.fda.gov/AnimalVeterinary/Ne ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Thu Jul 27, 2017 10:37 am

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

EZ Weight Loss TX LLC Issues Voluntary Nationwide Recall of Atomic and Xplode Capsules Due to the Presence of Undeclared Sibutramine

Corpus Christi, TX, EZ Weight Loss TX is voluntarily recalling all lots of La Bri's Body Health Atomic and Xplode capsules to the consumer level. FDA analysis has found the products to be tainted with sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons. The presence of sibutramine in these products renders it an unapproved drug for which safety and efficacy have not been established and, therefore subject to recall.


https://www.fda.gov/Safety/Recalls/ucm5 ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Thu Jul 27, 2017 10:39 am

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

Cantrell Drug Company Issues Voluntary Nationwide Recall of All Sterile Drug Products Due to Lack of Sterility Assurance

Cantrell Drug Company is voluntarily recalling all lots of unexpired sterile drug products to the hospital and user level due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide, except to the states of Connecticut, Hawaii, South Carolina and Vermont. To date, Cantrell has not received any reports of adverse events.


https://www.fda.gov/Safety/Recalls/ucm5 ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Mon Jul 31, 2017 3:08 pm

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

Bush Brothers & Company® Recalls Certain Baked Beans in 28 Ounce Cans Due to a Can Seam Issue

Bush Brothers & Company® Recalls Certain Baked Beans in 28 Ounce Cans Due to a Can Seam Issue

The recalled products were distributed nationwide in retail stores.


https://www.fda.gov/Safety/Recalls/ucm5 ... ovdelivery
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Re: FDA 2017

Postby ajsuff » Tue Aug 01, 2017 2:27 pm

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

Good Dog, Bad Food: Foods for People That Are Bad for Your Dog

Some foods that are meant for people can be dangerous, and even deadly, to your dog.


Learn more about which foods are unsafe for your dog to eat.
https://www.fda.gov/ForConsumers/Consum ... ovdelivery
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