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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Baxter Initiates Voluntary Recall of All Unexpired Lots of 50mm 0.2 Micron Filters
For Immediate Release
September 27, 2016
Contact
Consumers
Baxter
1-800-422-9837
Media
Eric Tatro
(224) 948-5353
Announcement
Deerfield, Ill. – Baxter International Inc. announced today it is voluntarily recalling all unexpired lots of 50mm 0.2 micron filters (product code H93835) due to the potential for a missing filter support membrane and for potential presence of particulate matter. These issues are associated with a component manufactured by an external supplier, and were identified prior to patient involvement as a result of complaints from customers at compounding facilities. There have been no adverse events reported to Baxter to date associated with these issues.
The 50mm 0.2 micron filter is a bacteria and particulate filter for aqueous solutions used during the compounding of solutions. In the absence of the filter support membrane, bacteria and/or particulate matter present in an unsterile solution could pass through to the compounded prepared solution. If not further filtered before patient administration, this could lead to adverse health consequences.
The recall affects the following lots:
Product Code
Product Description
Lot Number
Expiration Date
H93835
50mm 0.2 Micron Filter
All unexpired lots
6/27/2016 – 6/27/2019
The lots being recalled were distributed to customers and distributors globally between August 22, 2013 and June 20, 2016. Baxter is directing customers not to use the product from the recalled lots. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7 a.m. and 6 p.m., Central Time. Although the product has been discontinued for reasons unrelated to this recall, Baxter will work with customers to direct them toward suitable alternative products, if necessary.
Customers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8 a.m. and 5 p.m. Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.
Baxter is voluntarily conducting this recall with the knowledge of the U.S. Food and Drug Administration.
About Baxter
Baxter International Inc. provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Fred Meyer Recalls Deli Superfood Wrap Due to Undeclared Allergens
For Immediate Release
September 30, 2016
Contact
Consumers
Kroger
1-800-KROGERS
Media
Zach Stratton
1-971-258-1193
Melinda Merrill
1-503-708-8890
Announcement
Fred Meyer Stores has recalled a Deli BTG Superfood Wrap sold in its retail stores because the product may contain milk, soy, wheat and cashews not listed on the label.
People who are allergic to milk, soy, wheat or cashews could have a severe reaction if they consume this product. For consumers who are not allergic to those four allergens, there is no safety issue with the product. One Fred Meyer customer has reported a possible allergic reaction in connection with this product.
This product was sold in the deli department of Fred Meyer stores located in Alaska, Idaho, Oregon and Washington.
Fred Meyer has removed this item from store deli cases and initiated its customer recall notification system that alerts customers who may have purchased recalled Class 1 products through register receipt tape messages and phone calls.
Fred Meyer is recalling the following item:
Product
UPC
Codes
Size
Deli BTG Superfood Wrap
41573 11053
Sell-By 9/29/2016 OR BEFORE
Varies
Customers allergic to milk, soy, wheat or cashews who have purchased the above product should not consume it and should return them to a store for a full refund or replacement.
Customers who have questions may contact Kroger at 1-800-KROGERS, Monday through Friday 5:00 am to 9:00 pm PT and Saturday through Sunday 5:00 am to 6:00 pm PT.
###
Every day, the Kroger Family of Companies makes a difference in the lives of eight and a half million customers and 431,000 associates who shop or serve in 2,781 retail food stores under a variety of local banner names in 35 states and the District of Columbia. Kroger and its subsidiaries operate an expanding ClickList offering – a personalized, order online, pick up at the store service – in addition to 2,240 pharmacies, 785 convenience stores, 323 fine jewelry stores, 1,423 supermarket fuel centers and 38 food production plants in the United States. Kroger is recognized as one of America’s most generous companies for its support of more than 100 Feeding America food bank partners, breast cancer research and awareness, the military and their families, and more than 145,000 community organizations including schools. A leader in supplier diversity, Kroger is a proud member of the Billion Dollar Roundtable.
John
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News Release
Silver Springs Farms, Inc. Recalls Beef Products Due to Possible E. Coli O157:H7 Contamination
Class I Recall
091-2016
Health Risk: High
Sep 30, 2016
Congressional and Public Affairs
Allie Ryan
(202) 720-9113
WASHINGTON, Sept. 30, 2016 – Silver Springs Farms, Inc., a Harleysville, Pa. establishment is recalling approximately 740 pounds of ground beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The ground beef items were produced on August 19, 2016. The following products are subject to recall: Label
20-lb cases containing 4 packages of 5-lb ground beef 80/20.
The products subject to recall bear establishment number “EST. 4771” inside the USDA mark of inspection. These items were shipped to a distributor in Virginia.
The problem was discovered during a routine verification sampling performed by Silver Springs Farms, Inc. There have been no confirmed reports of adverse reactions due to consumption of these products.
E. coli O157:H7 is a potentially deadly bacterium that can cause dehydration, bloody diarrhea and abdominal cramps 2–8 days (3–4 days, on average) after exposure the organism. While most people recover within a week, some develop a type of kidney failure called hemolytic uremic syndrome (HUS). This condition can occur among persons of any age but is most common in children under 5-years old and older adults. It is marked by easy bruising, pallor, and decreased urine output. Persons who experience these symptoms should seek emergency medical care immediately.
FSIS and the company are concerned that some product may be frozen and in consumers' freezers.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
FSIS advises all consumers to safely prepare their raw meat products, including fresh and frozen, and only consume ground beef that has been cooked to a temperature of160° F. The only way to confirm that ground beef is cooked to a temperature high enough to kill harmful bacteria is to use a food thermometer that measures internal temperature, http://1.usa.gov/1cDxcDQ.
Media and consumers with questions regarding the recall can contact Dan Fillippo, Owner, at (215) 256-4321.
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Graceleigh, Inc. Recalls Sammy’s Milk Baby Food Because of Possible Health Risk
For Immediate Release
September 30, 2016
Contact
Consumers
Sammy’s Milk
949-646-4628
Announcement
View Product Photos
Graceleigh, Inc. d/b/a Sammy’s Milk is recalling all lots of Sammy’s Milk Baby Food because of possible presence of Cronobacter, a bacteria that can cause severe and sometimes fatal blood infections or meningitis in infants and it may not provide adequate nutritional levels of iron.
Sammy’s Milk was distributed in California to Mother’s Markets retailers and through nationwide direct delivery from www.SammysMilk.com
This product comes in a 12.84oz white plastic container for all lot numbers with expiration dates of 11/2016 - 8/2018.
No illnesses have been reported to date.
This recall is being conducted as a result of the FDA’s determination that Sammy’s Milk is being marketed as an Infant Formula, not manufactured in compliance with infant formula regulations and testing to confirm the absence of the Cronobacter bacteria was not performed. Although Sammy’s Milk meets the FDA’s minimum requirement for iron content, there is no label warning that it contains low iron and supplementation may be necessary.
Consumers who have purchased Sammy’s Milk are urged to not consume and return it to the place of purchase for a full refund. Consumers with questions may contact the company at 949-646-4628, or email at recall@SammysMilk.com between 10am-5pm PST Monday through Friday.
John
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Homeopathic Teething Tablets and Gels: FDA Warning - Risk to Infants and Children
AUDIENCE: Consumer
ISSUE: The FDA is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. The FDA is currently investigating this issue, including testing product samples. The agency will continue to communicate with the public as more information is available.
Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy. The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.
BACKGROUND: Homeopathic teething tablets and gels are distributed by CVS, Hyland’s, and possibly others, and are sold in retail stores and online.
RECOMMENDATION: The FDA recommends that consumers stop using these products and dispose of any in their possession. Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels.
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
Read the MedWatch safety alert, including a link to the FDA News Release, at:
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Fresh Express Announces Precautionary Recall of a Limited Quantity of 11 oz. American Salad due to Possible Allergen Exposure
For Immediate Release
September 29, 2016
Contact
Consumers
Consumer Response Center
(800) 242-5472
Media
Donna Watkins
(512) 848-1698
Announcement
View Product Photos
Orlando, Florida – Fresh Express Incorporated is voluntarily conducting a precautionary recall of 480 cases of 11 oz. Fresh Express American Salad with a Product Code of G264A12A and Use-By Date of October 5, due to possible exposure to undeclared allergens (egg, milk, wheat, anchovy). Fresh Express representatives are coordinating with retail stores to ensure removal of the recalled product from store shelves where distributed in primarily southern states.
No illnesses are reported. No other Fresh Express products are included in this recall.
The recall is necessitated by the possible mistaken inclusion of a small number of Caesar Salad condiment packets with undeclared allergens in a limited quantity of American Salads. Although the condiments are in a separate clear packet and labeled “Caesar,” the ingredient list for the condiments is not included on the package label and consumers will not be aware that allergens are present.
In order to safeguard the health and wellbeing of consumers, Fresh Express is voluntarily recalling all product that could possibly contain the incorrect condiment packet during this isolated incident. In some individuals the consumption of an undisclosed allergen could be life-threatening.
Fresh Express takes all matters of food safety very seriously, including the issue of allergens. Company procedures and programs stringently follow all mandated regulations and focus on preventive measures designed to minimize potential risks. Fresh Express is coordinating closely with the U.S. Food and Drug Administration and is conducting a full investigation into this isolated event.
Consumers in possession of the recalled product should discard it. A refund is available where purchased or by contacting the Fresh Express Consumer Response Center toll-free at (800) 242-5472 during the hours of 8 a.m. to 7 p.m. Eastern time.
Recalled Product Details:
Fresh Express American Salad - 11 oz. bag
Product Code of G264A12A and Use-By Date of October 5, located in the upper right hand corner on the front of the bag
UPC Code of 0 71279 241005 located on the reverse side of the bag by the bar code
Recalled Product Distribution
Fresh Express Precautionary Recall, American Salad - 09/29/16
(No other Fresh Express Salads are included in this recall)
BRAND
PRODUCT NAME
SIZE
UPC
PRODUCTION CODE
BEST IF USED BY DATE
POSSIBLE DISTRIBUTION STATES
Fresh Express
American Salad
11 oz.
0 71279 241005 G264A127A
05-Oct
AL, FL, GA, NC, SC, TN
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Updated Recall Information: McCain Foods USA, Inc. Issues Expanded Allergy Alert on Undeclared Milk in Frozen Onion Rings Sold and Distributed Under Private Label Retailer Brands
For Immediate Release
September 28, 2016
Contact
Consumers
McCain Foods USA, Inc.
877-804-6198
Media
McCain US Communications
630-857-4931
Announcement
View Product Photos
LISLE, IL – McCain Foods USA, Inc. today announced it is expanding its voluntarily recall of retail, frozen onion rings to include two (2) additional private label retail branded products due to the use of incorrect packaging that does not declare milk as one of the ingredients. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
McCain Foods USA, Inc. is recalling the following products. Kroger Brand, 20 oz. Bag of Frozen Breaded Minced Onion Rings with any production date after March 9, 2015 and prior to July 24, 2015, and Fareway Brand, 20 oz. Bag of Frozen Breaded Onion Rings with any production date after March 9, 2015 and prior to June 5, 2015.
On September 23, 2016 McCain Foods USA, Inc. initially recalled frozen onion ring products sold under the following brands: Premium Pick 5 Mix and Match Brand/Save-A-Lot, 40 oz. Bag of Frozen Breaded Diced Onion Rings; Krasdale Brand, 16 oz. Bag of Frozen Onion Rings; Spartan Brand, 20 oz. Bag of Frozen Onion Rings; and Shur Fine Brand, 16 oz. Bag of Frozen Onion Rings. The products for this initial September 23, 2016 recall were manufactured after October 20, 2015 and prior to September 23, 2016. McCain has updated the Premium Pick 5 Mix and Match Brand recall period to be after October 20, 2015 and prior to March 16, 2016.
The production date code will begin with the letter “V” and can be found on the back of the package in the lower, right hand side or next to the cooking instructions. Production date is documented on the bag via the following format: VYYMMDD. V=Production Plant Impacted by Recall. YY=Year. MM= Month. DD=Day. For example, a product impacted by this recall with the production date of March 10, 2015 would have the following date code on the bag: V150310.
The following summarizes the recalled product information:
Premium Pick 5 Mix and Match Brand (40 oz.)
Retailer: Save-A-Lot Retail Grocery Stores
Start Date of Recalled Product: After October 20, 2015 V151020
End Date of Recalled Product: Prior to March 16, 2016 V160316
Krasdale Brand Frozen Onion Rings (16 oz.)
Retailer: C-Town, Bravo, AIM and Market Fresh Retail Grocery Stores
Start Date of Recalled Product: After October 20, 2015 V151020
End Date of Recalled Product: Prior to September 23, 2016 V160923
Spartan Brand Frozen Onion Rings (20 oz.)
Retailer: Spartan, Family Fare, Econo Foods and Martin’s Retail Grocery Store
Start Date of Recalled Product: After October 20, 2015 V15102
End Date of Recalled Product: Prior to September 23, 2016 V160923
Shur Fine Brand Frozen Onion Rings (16 oz.)
Retailer: Various Retail Grocery Stores
Start Date of Recalled Product: After October 20, 2015 V151020
End Date of Recalled Product: Prior to September 23, 2016 V160923
Kroger Brand Frozen Breaded Minced Onion Rings (20 oz.)
Retailer: Kroger, Fred Meyer, Ralph’s, Food 4 Less, QSC, Fry’s and Smith’s Retail Grocery Stores
Start Date of Recalled Product: After March 9, 2015 V150309
End Date of Recalled Product: Prior to July 24, 2015 V150724
Fareway Brand Frozen Breaded Onion Rings (20 oz.)
Retailer: Fareway Retail Grocery Stores
Start Date of Recalled Product: After March 9, 2015 V150309
End Date of Recalled Product: Prior to June 5, 2015 V150605
Consumers who have an allergy or severe sensitivity to milk are advised to check their freezers and should throw out unused product or return any of it to the place of purchase for a full refund.
To-date, there have been no reported illnesses associated with the consumption of these products.
Food safety remains a top priority for McCain Foods USA, Inc. and we have full confidence that all appropriate steps are being taken to protect our consumers. McCain is working cooperatively with the FDA and retailers to ensure the affected products are removed from the marketplace.
Consumers with concerns or questions about the recall should contact McCain Foods USA, Inc., at 877-804-6198 (Monday – Friday, 8 a.m. – 6 p.m. EST).
Original Release
http://www.fda.gov/Safety/Recalls/ucm522476.htm
John
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Drug to treat alcohol use disorder shows promise among drinkers with high stress
NIH-funded multi-site clinical trial suggests that smokers may also benefit.
A new medication that targets part of the brain’s stress system may help reduce alcohol use in people with alcohol use disorder (AUD), according to a new study by researchers at the National Institute on Alcohol Abuse and Alcoholism (NIAAA), part of the National Institutes of Health.
“Medications have become an important tool for treating alcohol use disorders, but current medications are not effective for all people with AUDs,” noted NIAAA Director George F. Koob, Ph.D. “We’re committed to developing new medications to provide effective therapy to a broader spectrum of people with AUDs.”
As reported online in the journal Neuropsychopharmacology, researchers led by Raye Litten, Ph.D., acting director of the NIAAA Division of Medications Development, conducted a randomized clinical trial of a new compound, called ABT-436, designed to block the effects of vasopressin, a neuropeptide produced in the hypothalamus of the brain.
“Vasopressin helps to regulate the pituitary adrenal axis and other brain circuits involved in emotion,” explained Dr. Litten. “As such, it plays a role in regulating stress, anxiety, and their interaction with AUD.”
Dr. Litten, first author Megan Ryan and their NIAAA colleagues worked with NIAAA’s multi-center Clinical Investigations Group, to recruit 144 alcohol-dependent adult men and women for the 12-week study. During a 28-day baseline period, female participants consumed at least 28 drinks per week, while male participants consumed at least 35 drinks per week. Participants were then randomized to receive either placebo tablets or ones containing the ABT-436 compound. Researchers monitored participants’ alcohol consumption, as well as their mood changes and smoking habits, as these are known to co-vary with alcohol consumption.
Researchers found that participants receiving ABT-436 experienced more days of alcohol abstinence than those receiving the placebo. In particular, participants who reported high levels of stress appeared to respond better to ABT-436, in that both the frequency of their drinking and the number of heavy drinking days they experienced decreased.
“Our findings suggest that potential future studies with drugs targeting vasopressin blockade should focus on populations of people with AUD who also report high levels of stress,” said first author Ryan, a clinical project manager in the NIAAA Division of Medications Development.
Smokers may be another population that could benefit from ABT-436. In addition to its effects on alcohol consumption, study participants receiving the new compound experienced a reduction in smoking. The researchers suspect that ABT-436 might be targeting the same areas in the brain that relate to withdrawal and stress, and, in the process, influencing both tobacco and alcohol use disorders. Additional research is needed to determine if that is the case.
The National Institute on Alcohol Abuse and Alcoholism (NIAAA), part of the National Institutes of Health, is the primary U.S. agency for conducting and supporting research on the causes, consequences, prevention, and treatment of alcohol use disorder, and alcohol problems. NIAAA also disseminates research findings to general, professional, and academic audiences. Additional alcohol research information and publications are available at www.niaaa.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
NIH…Turning Discovery Into Health®
Reference
Ryan ML, Falk DE, Fertig JB, Rendenbach-Mueller B, Katz DA, Tracy KA, M.L. et al (2016). Phase 2, Double-Blind, Placebo-Controlled Randomized Trial Assessing the Efficacy of ABT-436, a Novel V1b Receptor Antagonist, for Alcohol Dependence, Neuropsychopharmacology (link is external)
http://www.nature.com/npp/journal/vaop/naam/pdf/npp2016214a.pdf
John
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https://nihseniorhealth.gov/endoflife/addressingpain/01.html
End of Life
Addressing Pain
Dealing With Pain
Struggling with pain can be draining. It can affect mood, making someone seem angry and irritable. Pain can make it hard for someone to talk, to share thoughts and feelings. Untreated or poorly controlled pain can prevent a dying person from spending time with loved ones in a meaningful way.
Dying does not have to be painful. Experts believe that care for someone at the end of life should focus on treating pain without worrying about the person becoming “addicted.”
Easier To Prevent Than Relieve
Pain is easier to prevent than to relieve, and overwhelming pain is hard to manage. It is important to keep pain under control -- do not be afraid to take as much pain medicine as prescribed.
If the pain continues, ask your health care provider to help you contact a palliative care specialist or hospice provider. If these providers are not available, a pain specialist should be able to help. Any of these specialists will understand how to help relieve a dying person’s pain.
How You Can Help
To help a dying person get effective pain relief, follow these tips for describing, tracking, and communicating pain to the specialist or provider.
Help the dying person describe the pain in as much detail as possible, including where it is, what it feels like, how long it lasts, when it started, what makes it better, and what makes it worse.
Help the dying person keep a record to track the pain. You may want to use a number from 0 to 10 to describe the pain, with 10 being the worst pain the dying person can imagine and 0 being no pain at all.
When the dying person cannot communicate her or his pain or other symptoms, watch for and record other cues such as grimacing or agitation, which may signal the person needs symptom relief.
Treatment Decisions: Morphine and Other Opiates
Morphine is an opiate, a strong medicine used to treat serious pain that is not relieved by drugs such as acetaminophen (also known as Tylenol®) or ibuprofen (also known as Advil® or Motrin®). It is also given to ease the feeling of shortness of breath (dyspnea). Other opiates, like hydrocodone and oxycodone, are also used to treat serious pain.
Opioid drugs work by binding to opioid receptors in the brain, spinal cord, and other areas of the body. They reduce the sending of pain messages to the brain and reduce feelings of pain. They are safe and effective for the relief of pain when used as prescribed.
While serous pain may not be relieved by Tylenol® or Advil® alone, these medicines are often given along with morphine or other opiates to treat the underlying causes of a patient’s pain, such as inflammation.
Opioid Dosage Levels
Around-the-clock dosing, which provides regularly scheduled doses of opioids day and night, may be required to treat severe pain. Once pain is under control and the dose of opiate has been the same for several days, it may be possible to lower the dose of opiate gradually without the pain coming back.
This change in dose to meet a patient’s varying pain needs is called titration by health care providers. Titration should be done carefully and only under the supervision of your health care provider.
Experts recommend that anyone who has been taking opiates for more than two weeks should reduce his or her intake gradually over time, rather than stopping suddenly, so the body has time to adjust.
If Pain Is Not Well Controlled
If the pain is not well controlled with around-the-clock dosing, there is no need to wait until the pain is unbearable. Untreated or poorly controlled pain can become hard to manage, causing unnecessary suffering. Do not be afraid to ask the health care provider to increase the around-the-clock dose if pain does not go away or comes back.
Sometimes pain is episodic, meaning it returns before the end of a dose or as a result of an event such as being moved. If this happens, ask your provider for breakthrough or rescue dosing. This is a dose of an opiate given in addition to the patient’s usual dosing schedule.
Some people develop a tolerance for opiates, which means a stronger dose may be required to get and keep pain under control. Tolerance is not the same thing as addiction. A common treatment for tolerance is to switch to a different opiate medication. Such a change may restore a higher level of pain relief.
Side Effects
All opiates can cause nausea, drowsiness, confusion, constipation, and other side effects. However, as the dying person’s body adjusts to the medicine, most side effects (except constipation) will decrease or go away completely. Those side effects that remain are usually easy to manage, such as taking laxatives for constipation.
People near the end of life who have chronic, severe pain are often unable to get a good night’s rest. When first taken, opiates like morphine may result in an initial sedation period that lasts as long as 24 hours as the dying person catches up on lost sleep. With continuing doses, normal mental activity should resume.
Other Concerns About Opiate Use
Some people worry that the prescribed use of morphine and other opiates to treat severe pain in a dying person will lead to addiction or a premature death. It is important to weigh the benefits of using opiates to improve the quality of life for the person against such concerns.
Most experts believe the risk of addiction for people near the end of life who take morphine and other opiates for pain relief is very low. Studies show that a brain in pain reacts to morphine differently than a brain not in pain. People become addicted to or dependent on opiates when they take them for fun or when they do not have pain.
Most experts also think it is unlikely that morphine or other opiates will lead to a quicker death, especially if the dosing is managed carefully by a palliative care, hospice, or pain specialist. Studies have shown that when pain is well controlled with appropriate use of pain medications, including opiates, people live longer than those with the exact same condition whose pain is not well controlled.
For more specific questions or concerns about opiate use, talk to your health care provider.
John
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https://www.cpsc.gov/Recalls/2016/Advanced-Sports-International-Recalls
Advanced Sports International Recalls Bicycles Due to Fall Hazard
Recall date: September 27, 2016
Recall number: 16-270
Recall Summary
Name of product: Breezer and Fuji bicycles
Hazard: The top clamp of the seat post can crack, posing a fall hazard to the user.
Consumer Contact:
Advanced Sports International toll‐free at 888-286‐6263 from 9 a.m. to 5 p.m. ET Monday through Friday or online at www.fujibikes.com or www.breezerbikes.com and click on “Recall Notice” at the bottom of the page for more information.
Recall Details
Units:
About 3,000
Description:
This recall involves Advanced Sports International’s 2017 model year Breezer and Fuji bicycles. The aluminum bicycles come in a variety of colors. The seatposts are silver or black. The model name is printed on the frame of the bicycle. Recalled models include:
Fuji Bicycles
Absolute 1.3 Disc
Absolute 1.7 Disc
Absolute 1.7 Disc ST
Absolute 2.1
Addy 27.5 1.3
Addy 27.5 1.5
Addy 27.5 1.7
Nevada 27.5 1.5
Nevada 27.5 1.7
Nevada 27.5 1.9
Traverse 1.9 ST
Police Special 29
Breezer Bicycles
Downtown 3 ST
Downtown 7+
Downtown 7+ ST
Downtown 8
Downtown 8 ST
Incidents/Injuries:
None reported
Remedy:
Consumers should immediately stop riding the bicycles and take their bicycle to a local Breezer or Fuji Bicycles Dealer or contact Advanced Sports International for a free replacement top seat clamp.
Sold At:
Authorized Breezer and Fuji Bicycle dealers from June 2016 through July 2016 for between $400 and $900.
Importer(s):
Advanced Sports International, of Philadelphia, Pa.
Distributor(s):
Advanced Sports International, of Philadelphia, Pa.
Manufactured In:
China
John
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https://www.cpsc.gov/Recalls/2016/SmartPool-Recalls-Pool-Alarms
SmartPool Recalls Pool Alarms Due to Failure to Alert Consumers
Recall date: September 27, 2016
Recall number: 16-269
Recall Summary
Name of product: PE12 PoolEye pool alarms
Hazard: The ON/OFF activation switch on the pool alarm is reversed, which can cause the alarm to fail to alert consumers if a child enters the water.
Consumer Contact:
SmartPool toll-free at 888-560-7665 from 9 a.m. to 5 p.m. ET Monday through Friday, via email at info@smartpool.com, or online at www.smartpool.com and click on PE12 Recall link on the homepage for more information.
Recall Details
Units:
About 1,600
Description:
This recall includes the PE12 PoolEye submersible swimming pool alarms for aboveground pools. The submersible gray pool alarm consists of two attached components, a sensor tube with a float switch that is submerged under water and an audible sensor that is fixed to the outside of the pool. The siren has an ON/OFF activation switch. PoolEye is printed on the front of the siren. PE12 is printed on the manual and UPC code 628208165125 is printed on the product’s packaging.
Description:
This recall includes the PE12 PoolEye submersible swimming pool alarms for aboveground pools. The submersible gray pool alarm consists of two attached components, a sensor tube with a float switch that is submerged under water and an audible sensor that is fixed to the outside of the pool. The siren has an ON/OFF activation switch. PoolEye is printed on the front of the siren. PE12 is printed on the manual and UPC code 628208165125 is printed on the product’s packaging.
*Note: I do not know why this is shown twice
Incidents/Injuries:
None reported
Remedy:
Consumers should immediately contact SmartPool for a free replacement alarm. Always supervise children in and around water.
Sold At:
Family Leisure, Pool and Spa Depot and other authorized dealers and online at Amazon, Doheny Enterprise, Target, Walmart and other websites from June 2016 through July 2016 for between $70 and $80. The alarms were also provided at no cost as part of a pool package.
Importer(s):
SmartPool LLC, of Lakewood, N.J.
Distributor(s):
SmartPool LLC, of Lakewood, N.J.
Manufactured In:
Hong Kong
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Koffee Kup Bakery, Inc. Voluntarily Recalls Bread Products Due to Possible Presence of Plastic Pieces in Product
For Immediate Release
September 17, 2016
Contact
Consumers
Koffee Kup Bakery, Inc
1-800-841-8102
Announcement
View Product Photos
Burlington, VT - Koffee Kup Bakery, Inc. has voluntarily recalled approximately 99,000 packages of its bread products due to the possibility that there may be clear plastic pieces in some products. The product recall is limited to the bread products listed below and only those identified by the “use by” dates 9/30/16, 10/1/16, 10/2/16 or 10/3/16, which are printed on the closure tags of each package. Products bearing other “use by” dates were not affected, nor were any of Koffee Kup’s crullers or donuts, which are produced on a different manufacturing line.
Koffee Kup discovered the presence of a foreign object in its bread and roll production through routine screening. The company ceased production immediately and upon further investigation, discovered that a small piece of clear plastic entered the stream of production and broke apart during the production process, thus creating a hard-material choking hazard. The company elected to commence an immediate product recall of all products potentially contaminated by the plastic that entered the production stream.
The recalled products were shipped to U.S. retailers in the states of VT, NH, ME, MA, CT, RI, NY, NJ, PA, MD,VA, and the District of Columbia. None of the products were shipped by Koffee Kup or its distributors to Canada or to other countries, to the company’s knowledge.
The following Koffee Kup products may be affected. No Koffee Kup products other than those identified below bearing “use by” dates 9/30/16, 10/1/16, 10/2/16 or 10/3/16 were affected.
Seeded Potato Hamburger Buns
Potato Hoagie Rolls
Koffee Kup Sub Rolls
Kaiser Rolls
Koffee Kup Wheat Sub Rolls
Koffee Kup Wheat Hamburger
Seeded Kaiser Roll Poppy
Koffee Kup Kaiser Rolls(Corn)
12 Hot Dog Buns
Wheat Hoagie Rolls
Koffee Kup Kaiser Rolls(White)
Potato Hot Dog Buns
Sourdough Hoagie Rolls
Koffee Kup Kaiser Rolls(Wheat)
12 Burger Buns
Sandwich Rolls
Market Basket Plain Bulkie Rolls
Koffee Kup Hot Dog Rolls
Grinder Rolls
Market Basket Wheat Bulkie Rolls
Market Basket Plain Sub Rolls
Wheat Kaiser Rolls
Bar-B-Que Sweet Buns
Hot Dog Buns
Wheat Grinder Rolls
Seeded Sandwich Buns
Hamburger Buns
Koffee Kup Hamburger Buns
Big Y Bulkie Rolls
Seeded Kaiser Rolls Sesame
Big Y enriched White Grinders
Big Y enriched Wheat Grinders
Hamb 5.5” Plain 8 PK
Hamb 5.5” Seed 8PAK
Distributors, drivers and retailers have been notified of the recall and have been directed to remove all potentially-affected products from stores, but some products may already have been purchased by consumers. Customers who purchased any of the above-listed products should NOT eat the product, but should return it to the store where it was purchased for an exchange or a full refund. When possible, customers are asked to return the product with the bag and closing clip.
No injuries have been reported to date.
Consumers with questions can contact Koffee Kup Bakery, Inc. at 1-800-841-8102.
John
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DePuy Synthes Recalls Power Tool System Battery Adaptors Due to Possible Explosion Risk
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product:
Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II
Serial Numbers: 05.001.024 and 05.001.108
Manufacturing Dates: October 6, 2005 to April 5, 2016
Distribution Dates: January 2006 to June 2016
Devices Recalled in the U.S.: 451 units distributed nationwide
Device Use
The Adaptor and Light Adaptor are power sources for the DePuy Synthes Small Battery Drive (SBD) and the Small Battery Drive II (SBD II) surgical power tool systems. The SBD and SBD II power the Synthes Power Tool system, which includes attachments for drilling or cutting bone in orthopedic surgery.
The adaptors and surgical tool systems are only used in hospitals and other health care facilities.
Reason for Recall
DePuy Synthes is recalling the Adaptor and Light Adaptor for their SBD and SBD II due to a potential for the adaptors to produce extreme internal pressure, which may cause the device to explode.
The use of affected products may cause serious adverse health consequences, including death.
Who May be Affected
Surgeons and other health care providers using the Adaptor and Light Adaptor SBD and SBD II with their DePuy Synthes Power Tool systems.
Patients undergoing surgeries involving these tool systems and adaptors.
Bystanders or other staff who are in an operating room where these tool systems and adaptors are used.
What to Do
On January 15, 2016, DePuy Synthes sent an "Urgent Notice-Medical Device Recall” letter to all affected customers. The letter asked customers to:
Identify and quarantine the device
Contact DePuy Synthes Customer Support at 1-800-327-6887, to obtain a Return Materials Authorization Number
Complete and return the Verification Section of the device recall letter to The Anspach Effort Inc. at 4500 Riverside Drive, Palm Beach Gardens, FL 33410
Send a copy of the Verification Section to DePuy Synthes, Customer Quality Department through:
Fax: 561-627-2682 or
Scan/email: DPYUS-PowerToolsFieldActions.its.jnj.com
Keep the recall notice visibly posted in your facility for awareness
Contact Information
Health care professionals and consumers with questions are instructed to contact the Customer Quality at-1-800-327-6687 #3, with any questions related to this recall.
Date Recall Initiated:
June 24, 2016
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program
https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
either online, by regular mail or by FAX to 1-800-FDA-0178.
John
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News Release
Caviness Beef Packers Recalls Beef Products Due to Possible E. Coli O103 Contamination
Class I Recall
090-2016
Health Risk: High
Sep 27, 2016
Distribution List PDF
Congressional and Public Affairs
Allie Ryan
(202) 720-9113
WASHINGTON, Sept. 27, 2016 – Caviness Beef Packers, a Hereford, Texas establishment, is recalling approximately 2,100 pounds of boneless beef trim products that may be contaminated withE. coli O103, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The 2,100-lb. Combo Bin of “boneless beef trim 84L” products were produced on September 14, 2016 and further processed into ground beef products by another establishment. The recalling establishment has control of all but 320 pounds of ground beef products.
10 lb. chub - 73% Regular Ground Beef products with a “Use By” or “Freeze By” date of October 10, 2016 and bear UPC number 52846-48935.
2-3 lb. tray pack of - 73% Regular Ground Beef products with a “Sell By” date of September 28, 2016 and bear UPC number 2-01656-00000.
1.5 lb. tray pack of - 73% Regular Ground Beef products with a “Sell By” date of September 28, 2016 and bear UPC number 2-01654-00000.
The products subject to this recall were further processed by a firm other than Caviness Beef Packers, “EST. 675” and may not bear the establishment number "EST. 675", on products available for direct consumer purchase. These products were shipped to retail locations in Texas.
The problem was discovered when FSIS was notified of a USDA’s Agricultural Marketing Service (AMS) sample that tested positive for E. coli 0103. Because the company works with the AMS Commodity Program, AMS did routine microbiological testing. This shipment of beef was never intended for the National School Lunch Program (NLSP) and no sales were made to the NLSP. There have been no confirmed reports of adverse reactions due to consumption of these products.
Many clinical laboratories do not test for non-O157 Shiga toxin-producing E. coli (STEC), such as STEC O103 because it is harder to identify than STEC O157. People can become ill from STECs 2–8 days (average of 3–4 days) after consuming the organism. Most people infected with STEC O103 develop diarrhea (often bloody), and vomiting. Some illnesses last longer and can be more severe. Infection is usually diagnosed by testing of a stool sample. Vigorous rehydration and other supportive care is the usual treatment; antibiotic treatment is generally not recommended.
Most people recover within a week, but, rarely, some develop a more severe infection. Hemolytic uremic syndrome (HUS) is uncommon with O103 infection. HUS can occur in people of any age but is most common in children under 5 years old, older adults and persons with weakened immune systems. It is marked by easy bruising, pallor, and decreased urine output. Persons who experience these symptoms should seek emergency medical care immediately.
FSIS and the company are concerned that some product may be frozen and in consumers' freezers.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
FSIS advises all consumers to safely prepare their raw meat products, including fresh and frozen, and only consume ground beef that has been cooked to a temperature of 160° F. The only way to confirm that ground beef is cooked to a temperature high enough to kill harmful bacteria is to use a food thermometer that measures internal temperature, http://1.usa.gov/1cDxcDQ.
Media and consumers with questions regarding the recall can contact Trevor Caviness, President, at (806) 372 - 5781.
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Café Valley Inc. Issues Allergy Alert on Undeclared (Walnuts) In 12ct Banana Nut Mini Muffins Labeled as 12ct Lemon Poppy Seed Mini Muffins
For Immediate Release
September 26, 2016
Contact
Consumers
Café Valley Inc.
623-866-7383
Media
Nate Hocking
602-336-2142
Announcement
View Product Photos
Café Valley of Marion, Indiana is recalling 543 cases of Banana nut mini muffins labeled as Lemon poppy seed mini muffins, because they may contain undeclared walnuts. People who have an allergy or severe sensitivity to walnuts run the risk of serious or life-threatening allergic reaction if they consume these products.
Product was distributed to wholesale distributors in Kansas, Mississippi, Tennessee, Missouri, Ohio, Massachusetts, Vermont, Alabama, and Illinois.
The product is Café Valley Brand 12ct Banana Nut mini muffins, with a Lemon Poppy Seed mini muffin label. Date code 160803 ink jet printed on top near the label.
No illnesses have been reported to date.
The recall was initiated after it was discovered that product containing walnuts was distributed in packaging that did not reveal the presence of walnuts, as it was misbranded with a lemon poppy seed label. Subsequent investigation indicates the problem was caused by a partial roll of the previous run of product labels, which was inserted into the production of the banana nut production run.
Consumers who have purchased the Café Valley Mini Muffins are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company customer service Monday through Friday from 7:30am-4:30pm, phone: 623-866-7383.
John
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News Release
Adams Farm Slaughterhouse Recalls Beef, Veal, And Bison Products Due To Possible E. Coli O157:H7 Adulteration
Class I Recall
087-2016
Health Risk: High
Sep 24, 2016
Distribution List PDF
Congressional and Public Affairs
Jeremy J.Emmert
(202) 720-9113
WASHINGTON, September 24, 2016 – Adams Farm Slaughterhouse, LLC, an Athol, Mass., establishment, is recalling beef, veal, and Bison products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The raw intact and non-intact beef products originated from animals slaughtered on July 15, 25, and 27, 2016 and August 3, 8, 10, 11, 17, 24 and 26, 2016, and further processed and packed on various dates between July 21, and September 22, 2016.
The products subject to recall bear establishment number EST. 5497 inside the USDA mark of inspection and have lot numbers:
120361, 121061, 121761, 121861, 122161, 122261, 122361, 122461, 122861, 123061, 123161, 123261, 123561, 123661, 123861, 124561, 125261, 125861, 125961, 124261, 120461, 120961, 121161, 121661, 124461, 125061, 126661.
The products subject to this recall include:
WHOLE BEEF CARCASSES, BEEF CUTS, BEEF TRIM, BEEF FOR STEWING, BEEF FLAT IRON, CHUCK ROAST BONE/IN, CHUCK ROAST BONELESS, ROLLED CHUCK ROAST, STANDING RIB ROAST, ROLLED RIB ROAST, RIB EYE STEAK WITH/BONE, RIB EYE STEAK BONELESS, BONELESS RIB EYE STEAK, DELMONICO STEAK, SIRLOIN STEAK, NY STRIP STEAK, SIRLOIN STRIP STEAK, T-BONE STEAK, PORTERHOUSE STEAK, TENDERLOIN STEAK, BONELESS NY SIRLOIN STEAK, SIRLOIN STEAK, NY SIRLOIN STEAK BONE/IN, EYE ROUND ROAST, TOP ROUND STEAK, TOP ROUND ROAST, BEEF KABOBS MADE FROM TOP ROUND, SHOULDER ROAST, LONDON BROIL STEAK CUT FROM THE SHOULDER, BOTTOM ROUND ROAST, FACE RUMP ROAST, TRI TIP ROAST, LONDON BROIL STEAK MADE FROM ROUND, SKIRT STEAK, FLANK STEAK, GROUND BEEF, GROUND BEEF PATTIES, BEEF LOIN NY SHELL STEAK, BEEF CLUB STEAK, BEEF HEART, BEEF LIVER, BEEF OXTAIL, WHOLE LIVER, BEEF BRISKET, WHOLE TENDERLOIN, FACE RUMP, BOTTOM ROUND FLAT, WHOLE CHUCK BONE/IN, WHOLE CHUCK BONELESS, WHOLE RIB EYE, WHOLE SIRLOIN STRIP, TOP BUTT, WHOLE TOP ROUND, AND BEEF SOUP BONES (SHANKS).
VEAL WHOLE CARCASS, VEAL CUTS, VEAL TRIM, OSSO BUCO, VEAL STEW MEAT, GROUND VEAL, VEAL SHOULDER, VEAL RIB CHOPS, VEAL LOIN CHOPS, VEAL STEAKS, VEAL ROUND STEAK, VEAL CUTLETS, VEAL TENDERLOIN, VEAL ROAST.
The recalled product includes product from Bison slaughtered on August 17:
BISON CUTS, BISON TRIM, BISON FOR STEWING, BISON FLAT IRON, CHUCK ROAST BONE/IN, CHUCK ROAST BONELESS, ROLLED CHUCK ROAST, STANDING RIB ROAST, ROLLED RIB ROAST, RIB EYE STEAK WITH/BONE, RIB EYE STEAK BONELESS, BONELESS RIB EYE STEAK, DELMONICO STEAK, SIRLOIN STEAK, NY STRIP STEAK, SIRLOIN STRIP STEAK, T-BONE STEAK, PORTERHOUSE STEAK, TENDERLOIN STEAK, BONELESS NY SIRLOIN STEAK, SIRLOIN STEAK, NY SIRLOIN STEAK BONE/IN, EYE ROUND ROAST, TOP ROUND STEAK, TOP ROUND ROAST, BISON KABOBS MADE FROM TOP ROUND, SHOULDER ROAST, LONDON BROIL STEAK CUT FROM THE SHOULDER, BOTTOM ROUND ROAST, FACE RUMP ROAST, TRI TIP ROAST, LONDON BROIL STEAK MADE FROM ROUND, SKIRT STEAK, FLANK STEAK, GROUND BISON, GROUND BISON PATTIES, BISON LOIN NY SHELL STEAK, BISON CLUB STEAK, BISON HEART, BISON LIVER, BISON OXTAIL, WHOLE LIVER, BISON BRISKET, WHOLE TENDERLOIN, FACE RUMP, BOTTOM ROUND FLAT, WHOLE CHUCK BONE/IN, WHOLE CHUCK BONELESS, WHOLE RIB EYE, WHOLE SIRLOIN STRIP, TOP BUTT, WHOLE TOP ROUND, AND BISON SOUP BONES (SHANKS).
These items were shipped to farmer’s markets, retail locations, and restaurants in Massachusetts, Connecticut, and eastern New York. The products may have been shipped to neighboring states in the immediate area.
FSIS was notified of an investigation of E. coli O157:H7 illnesses on September 16, 2016. Working in conjunction with the Connecticut Department of Public Health, the Massachusetts Department of Public Health, and the Centers for Disease Control and Prevention, FSIS determined that there is a link between beef from Adams Farm Slaughterhouse and this illness cluster. Based on the epidemiological investigation, 7 case-patients have been identified in Connecticut, Massachusetts, Pennsylvania, and West Virginia with illness onset dates ranging from June 27, 2016 to September 4, 2016. Traceback information was available for 5 case-patients and indicated that all 5 case-patients consumed beef products supplied by Adams Farms Slaughterhouse. FSIS continues to work with public health partners on this investigation and will provide updated information as it becomes available.
E. coli O157:H7 is a potentially deadly bacterium that can cause dehydration, bloody diarrhea and abdominal cramps 2–8 days (3–4 days, on average) after exposure the organism. While most people recover within a week, some develop a type of kidney failure called hemolytic uremic syndrome (HUS). This condition can occur among persons of any age but is most common in children under 5-years old and older adults. It is marked by easy bruising, pallor, and decreased urine output. Persons who experience these symptoms should seek emergency medical care immediately.
FSIS and the company are concerned that some product may be frozen and in consumers' freezers.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
FSIS advises all consumers to safely prepare their raw meat products, including fresh and frozen, and only consume beef and ground meat that has been cooked to a temperature of 145° F for beef (with a three minute rest time) and 160° F for ground meat. The only way to confirm that your meat products have been cooked to a temperature high enough to kill harmful bacteria is to use a food thermometer that measures internal temperature, http://1.usa.gov/1cDxcDQ.
Media and consumers with questions regarding the recall can contact Ed Maltby, General Manager of Adams Farm Slaughterhouse at (978) 249-9441 x 105.
John
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News Release
Tyson Foods Inc. Recalls Chicken Nugget Products Due To Possible Foreign Matter Contamination
Class I Recall
089-2016
Health Risk: High
Sep 27, 2016
Congressional and Public Affairs
Maria Machuca
(202) 720-9113
WASHINGTON, Sept. 27, 2016 – Tyson Foods Inc., a Sedalia, Mo. establishment, is recalling approximately 132,520 pounds of fully cooked chicken nugget products that may be contaminated with hard plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The fully cooked Panko Chicken Nuggets items were produced on July 18, 2016. The following products are subject to recall:
View Labels PDF Only
5-lb. bag containing “Tyson FULLY COOKED PANKO CHICKEN NUGGETS” with a “Best If Used By” date of July 18, 2017 and case code 2006SDL03 and 2006SDL33.
20-lb. bulk packages containing “SPARE TIME Fully Cooked, Panko Chicken Nuggets, Nugget Shaped Chicken Breast Pattie Fritters With Rib Meat” with a production date of July 18, 2016 and case code 2006SDL03.
The products subject to recall bear establishment number “EST. 13556” printed adjacent to the “Best If Used By” date on the back of the package. The 20-pound cases were shipped for institutional use in Pennsylvania and the five-pound bags were shipped to retail locations nationally.
The problem was discovered after the firm received consumer complaints regarding foreign material contamination of chicken nugget products. According to Tyson Foods, the plastic material ranged in size from 21mm in length and 6.5mm in diameter and may have come from a round, hard plastic rod used to connect a plastic transfer belt. The firm said the products pass through a metal detector, but the plastic is not detectable to this technology.
There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Consumers with questions about the recall can contact Tyson Foods’ Consumer Relations at (866) 328-3156. Media with questions about the recall can contact Worth Sparkman-Public Relations, Corporate Affairs, at (479) 290-6358.
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
McCain Foods USA, Inc. Announces a Product Recall Impacting Frozen Onion Rings Sold and Distributed Under Four Separate Private Label Retail Brands
For Immediate Release
September 23, 2016
Contact
Consumers
McCain Foods
630-857-4329
Media
McCain US Communications
630-857-4931
Announcement
View Product Photos
Lisle, IL - McCain Foods USA, Inc. today announced it is voluntarily recalling retail, frozen onion ring products due to the use of incorrect packaging that does not declare milk as one of the ingredients. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
These frozen onion ring products are sold under the following brands/retail locations: Save-A-Lot Stores (40oz Bag of Frozen Breaded Diced Onion Rings, Premium Pick 5 Mix and Match Brand), Krasdale Brand (16oz Bag of Frozen Onion Rings), Spartan Brand (20oz Bag of Frozen Onion Rings) and Shur Fine Brand (16oz Bag of Frozen Onion Rings).
No other products are impacted by this recall.
The products being recalled have been manufactured after October 20th, 2015 and prior to September 23, 2016. The production date code will begin with the letter “V” on the bag. Production date is documented on the bag via the following format: VYYMMDD. V=Production Plant Impacted By Recall. YY = Year. MM = Month. DD=Day.& Therefore, packages with date codes after October 20, 2015 [V151020] and prior to September 23, 2016 [V160923] are a part of the recall.
Consumers who have an allergy or severe sensitivity to milk are advised to check their freezers and should throw out unused product or return any of it to the place of purchase for a full refund.
There have been no reported illnesses associated with the consumption of this product.
Food safety remains a top priority for McCain Foods USA, Inc. and we have full confidence that all appropriate steps are being taken to protect our consumers. McCain is working cooperatively with the FDA and retailers to ensure the affected products are removed from the marketplace.
Consumers with concerns or questions about the recall should contact McCain Foods at (630) 857-4329.
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Mt Kisco Smokehouse Recalls Smoked Salmon Because of Possible Health Risk
For Immediate Release
September 26, 2016
Contact
Consumers
Mt Kisco Smokehouse
(914) 244-0702
Announcement
View Product Photos
Mt Kisco Smokehouse of Mt Kisco, NY, is voluntarily recalling two types of smoked salmon 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.
Atlantic Smoked Salmon Whole
lot # 13723516 USE BY 09 12 16
lot # 12125316 USE BY 09 30 16
Sliced – Smoked ATLANTIC SALMON, Net Wt. 8 Oz (225.89)
lot # 12125116 USE BY 09 28 16
lot # 12125216 USE BY 09 29 16
lot # 11325716 USE BY 10 03 16
lot # 11325816 USE BY 10 05 16
Product was distributed in New York and Connecticut through retail stores and restaurants between 9/6/2016 to 9/16/2016.
The whole product is packed in an unlabeled paper box and delivered to restaurants. The sliced product is sold in a clear plastic package and labeled on the back with lot and use by date.
No illnesses have been reported to date in connection with this problem.
The potential for contamination was noted after routine testing by the FDA inspection revealed the presence of Listeria monocytogenes in floor drains and cracks in the floor.
The production of the product has been suspended while FDA and the company continue to investigate the source of the problem.
Consumers who have purchased the items are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 914-244-0702, Monday through Saturday 9:00 am – 5:30 pm, EST.
John
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Monday, September 26, 2016
NIH study links morning sickness to lower risk of pregnancy loss
Comprehensive study confirms earlier reports.
A new analysis by researchers at the National Institutes of Health has provided the strongest evidence to date that nausea and vomiting during pregnancy is associated with a lower risk of miscarriage in pregnant women. The study, appearing in JAMA Internal Medicine, was conducted by researchers at NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and other institutions.
Nausea and vomiting that occurs in pregnancy is often called “morning sickness,” as these symptoms typically begin in the morning and usually resolve as the day progresses. For most women, nausea and vomiting subside by the 4th month of pregnancy. Others may have these symptoms for the duration of their pregnancies. The cause of morning sickness is not known, but researchers have proposed that it protects the fetus against toxins and disease-causing organisms in foods and beverages.
“It’s a common thought that nausea indicates a healthy pregnancy, but there wasn’t a lot of high-quality evidence to support this belief,” said the study’s first author, Stefanie N. Hinkle, Ph.D, a staff scientist in NICHD’s Epidemiology Branch. “Our study evaluates symptoms from the earliest weeks of pregnancy, immediately after conception, and confirms that there is a protective association between nausea and vomiting and a lower risk of pregnancy loss.”
For their study, Dr. Hinkle and her colleagues analyzed data from the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial, in which researchers tested whether taking daily low-dose aspirin prevents women who experienced one or two prior pregnancy losses from experiencing a future loss.
The authors looked at data from all the women in the study who had a positive pregnancy test. The women kept daily diaries of whether they experienced nausea and vomiting in the 2nd through the 8th week of their pregnancies and then responded to a monthly questionnaire on their symptoms through the 36th week of pregnancy. The study authors noted that most previous studies on nausea and pregnancy loss were not able to obtain such detailed information on symptoms in these early weeks of pregnancy. Instead, most of studies had relied on the women’s recollection of symptoms much later in pregnancy or after they had experienced a pregnancy loss.
In the EAGeR trial, a total of 797 women had positive pregnancy tests, with 188 pregnancies ending in loss. By the 8th week of pregnancy, 57.3 percent of the women reported experiencing nausea and 26.6 percent reported nausea with vomiting. The researchers found that these women were 50 to 75 percent less likely to experience a pregnancy loss, compared to those who had not experienced nausea alone or nausea accompanied by vomiting.
About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD conducts and supports research in the United States and throughout the world on fetal, infant and child development; maternal, child and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit NICHD’s website.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Limited Number of Canned Vegetable Products, Primarily Non-Retail, Recalled for Possible Allergen Risk
For Immediate Release
September 23, 2016
Contact
Consumers
1-800-543-3090
Announcement
View Product Photos
Walnut Creek, CA – Sager Creek Foods, Inc., a subsidiary of Del Monte Foods, Inc., announced a recall of approximately 15,000 shipped cases of FIELD PEAS WITH SNAPS and GREEN BEAN PRODUCTS, primarily non-retail, which may have the potential for trace amounts of shellfish contamination. A customer alerted Sager Creek to the incident.
Of the 15,000 cases being recalled, 14,761 (98.5 percent) were distributed to foodservice customers. The product was shipped to 22 states: (AL, AR, CO, IL, MD, MO, MS, FL, GA, KS, KY, LA, OK, PA, NC, SC, TN, TX, UT, VA, WI, WV).
No illnesses have been reported in connection with this issue to date. There is no risk for people who do not have a shellfish allergy.
The products are sold in 106 ounce metal cans with Best By Dates of JUN 01 19 printed on the top and contain the following UPC codes and product names:
0 34700 01224 4
Allens Cut Green Beans
0 34700 01224 7
Allens Cracker Barrel Label
0 74865 12172 9
Reliance BL Cut Green Beans
7 58108 01041 3
Monarch SWD Cut Green Beans
7 58108 01048 2
Monarch Mixed Cut Green Beans
8 06795 04718 9
Silver Source SH/C Green Beans
0 74865 02895 9
Reliance MX/SH Cut Green Beans
0 34700 63214 8
Allens Field Peas with Snaps
Shellfish is an allergen that can cause serious and sometimes fatal reaction in people with shellfish allergy. Shellfish allergy symptoms differ from person to person and it may include hives, watery eyes, swelling of face, lips, tongue and hands, coughing & wheezing, vomiting, diarrhea, or anaphylaxis.
If customers or consumers have any of the listed products with the indicated UPC codes and Best By dates, they should return it to the place of purchase for a full refund. Consumers with questions may contact the company by calling the toll-free hotline at 1-800-543-3090, Monday-Friday, 9:00 am – 5:00 pm Eastern Time or by logging onto www.delmontefoods.com.
John
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News Release
Kiwi Care Package Company Recalls Wattie’s Canned Spaghetti With Sausage Products Distributed Without Benefit Of Import Inspection
Class I Recall
088-2016
Health Risk: High
Sep 24, 2016
Congressional and Public Affairs
Jeremy J. Emmert
(202) 720-9113
WASHINGTON, Sept. 24, 2016 - Kiwi Care Package Company, a South Tahoe, Calif., establishment, is recalling approximately 90 pounds of Wattie’s canned spaghetti with sausage that was not presented at the U.S. point of entry for inspection and was received from a New Zealand establishment that was not eligible to export product to the U.S., the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. Without the benefit of full inspection, a possibility of adverse health consequences exists.
The product was imported on September 1, 2016. The following products are subject to recall:
Labels PDF Only
137 cans weighing 300 grams each labeled “Wattie’s Spaghetti with Sausages ‘100% Lamb & BEEF.’”
The products subject to recall bear New Zealand establishment number “PH233”. The product was sold through the internet.
The problem was discovered on September 22, 2016, by FSIS during routine monitoring of import shipments. On September 23, 2016, FSIS confirmed that there was a failure to present shipment and the products were already in commerce without receiving FSIS re-inspection upon entry to the United States. Additionally, it was determined that the product was not produced by an establishment in New Zealand eligible to export to the United States.
There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Consumers with questions about the recall can contact Katie Joll, owner at info@kiwicarepackage.com.
John
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News Release
Adams Farm Slaughterhouse Recalls Beef, Veal, And Bison Products Due To Possible E. Coli O157:H7 Adulteration
Class I Recall
087-2016
Health Risk: High
Sep 24, 2016
Congressional and Public Affairs
Jeremy J.Emmert
(202) 720-9113
WASHINGTON, September 24, 2016 – Adams Farm Slaughterhouse, LLC, an Athol, Mass., establishment, is recalling beef, veal, and Bison products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The raw intact and non-intact beef products originated from animals slaughtered on July 15, 25, and 27, 2016 and August 3, 8, 10, 11, 17, 24 and 26, 2016, and further processed and packed on various dates between July 21, and September 22, 2016.
The products subject to recall bear establishment number EST. 5497 inside the USDA mark of inspection and have lot numbers:
120361, 121061, 121761, 121861, 122161, 122261, 122361, 122461, 122861, 123061, 123161, 123261, 123561, 123661, 123861, 124561, 125261, 125861, 125961, 124261, 120461, 120961, 121161, 121661, 124461, 125061, 126661.
The products subject to this recall include:
WHOLE BEEF CARCASSES, BEEF CUTS, BEEF TRIM, BEEF FOR STEWING, BEEF FLAT IRON, CHUCK ROAST BONE/IN, CHUCK ROAST BONELESS, ROLLED CHUCK ROAST, STANDING RIB ROAST, ROLLED RIB ROAST, RIB EYE STEAK WITH/BONE, RIB EYE STEAK BONELESS, BONELESS RIB EYE STEAK, DELMONICO STEAK, SIRLOIN STEAK, NY STRIP STEAK, SIRLOIN STRIP STEAK, T-BONE STEAK, PORTERHOUSE STEAK, TENDERLOIN STEAK, BONELESS NY SIRLOIN STEAK, SIRLOIN STEAK, NY SIRLOIN STEAK BONE/IN, EYE ROUND ROAST, TOP ROUND STEAK, TOP ROUND ROAST, BEEF KABOBS MADE FROM TOP ROUND, SHOULDER ROAST, LONDON BROIL STEAK CUT FROM THE SHOULDER, BOTTOM ROUND ROAST, FACE RUMP ROAST, TRI TIP ROAST, LONDON BROIL STEAK MADE FROM ROUND, SKIRT STEAK, FLANK STEAK, GROUND BEEF, GROUND BEEF PATTIES, BEEF LOIN NY SHELL STEAK, BEEF CLUB STEAK, BEEF HEART, BEEF LIVER, BEEF OXTAIL, WHOLE LIVER, BEEF BRISKET, WHOLE TENDERLOIN, FACE RUMP, BOTTOM ROUND FLAT, WHOLE CHUCK BONE/IN, WHOLE CHUCK BONELESS, WHOLE RIB EYE, WHOLE SIRLOIN STRIP, TOP BUTT, WHOLE TOP ROUND, AND BEEF SOUP BONES (SHANKS).
VEAL WHOLE CARCASS, VEAL CUTS, VEAL TRIM, OSSO BUCO, VEAL STEW MEAT, GROUND VEAL, VEAL SHOULDER, VEAL RIB CHOPS, VEAL LOIN CHOPS, VEAL STEAKS, VEAL ROUND STEAK, VEAL CUTLETS, VEAL TENDERLOIN, VEAL ROAST.
The recalled product includes product from Bison slaughtered on August 17:
BISON CUTS, BISON TRIM, BISON FOR STEWING, BISON FLAT IRON, CHUCK ROAST BONE/IN, CHUCK ROAST BONELESS, ROLLED CHUCK ROAST, STANDING RIB ROAST, ROLLED RIB ROAST, RIB EYE STEAK WITH/BONE, RIB EYE STEAK BONELESS, BONELESS RIB EYE STEAK, DELMONICO STEAK, SIRLOIN STEAK, NY STRIP STEAK, SIRLOIN STRIP STEAK, T-BONE STEAK, PORTERHOUSE STEAK, TENDERLOIN STEAK, BONELESS NY SIRLOIN STEAK, SIRLOIN STEAK, NY SIRLOIN STEAK BONE/IN, EYE ROUND ROAST, TOP ROUND STEAK, TOP ROUND ROAST, BISON KABOBS MADE FROM TOP ROUND, SHOULDER ROAST, LONDON BROIL STEAK CUT FROM THE SHOULDER, BOTTOM ROUND ROAST, FACE RUMP ROAST, TRI TIP ROAST, LONDON BROIL STEAK MADE FROM ROUND, SKIRT STEAK, FLANK STEAK, GROUND BISON, GROUND BISON PATTIES, BISON LOIN NY SHELL STEAK, BISON CLUB STEAK, BISON HEART, BISON LIVER, BISON OXTAIL, WHOLE LIVER, BISON BRISKET, WHOLE TENDERLOIN, FACE RUMP, BOTTOM ROUND FLAT, WHOLE CHUCK BONE/IN, WHOLE CHUCK BONELESS, WHOLE RIB EYE, WHOLE SIRLOIN STRIP, TOP BUTT, WHOLE TOP ROUND, AND BISON SOUP BONES (SHANKS).
These items were shipped to farmer’s markets, retail locations, and restaurants in Massachusetts, Connecticut, and eastern New York. The products may have been shipped to neighboring states in the immediate area.
FSIS was notified of an investigation of E. coli O157:H7 illnesses on September 16, 2016. Working in conjunction with the Connecticut Department of Public Health, the Massachusetts Department of Public Health, and the Centers for Disease Control and Prevention, FSIS determined that there is a link between beef from Adams Farm Slaughterhouse and this illness cluster. Based on the epidemiological investigation, 7 case-patients have been identified in Connecticut, Massachusetts, Pennsylvania, and West Virginia with illness onset dates ranging from June 27, 2016 to September 4, 2016. Traceback information was available for 5 case-patients and indicated that all 5 case-patients consumed beef products supplied by Adams Farms Slaughterhouse. FSIS continues to work with public health partners on this investigation and will provide updated information as it becomes available.
E. coli O157:H7 is a potentially deadly bacterium that can cause dehydration, bloody diarrhea and abdominal cramps 2–8 days (3–4 days, on average) after exposure the organism. While most people recover within a week, some develop a type of kidney failure called hemolytic uremic syndrome (HUS). This condition can occur among persons of any age but is most common in children under 5-years old and older adults. It is marked by easy bruising, pallor, and decreased urine output. Persons who experience these symptoms should seek emergency medical care immediately.
FSIS and the company are concerned that some product may be frozen and in consumers' freezers.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
FSIS advises all consumers to safely prepare their raw meat products, including fresh and frozen, and only consume beef and ground meat that has been cooked to a temperature of 145° F for beef (with a three minute rest time) and 160° F for ground meat. The only way to confirm that your meat products have been cooked to a temperature high enough to kill harmful bacteria is to use a food thermometer that measures internal temperature, http://1.usa.gov/1cDxcDQ.
Media and consumers with questions regarding the recall can contact Ed Maltby, General Manager of Adams Farm Slaughterhouse at (978) 249-9441 x 105.
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Waymouth Farms, Inc. Issues an Allergy Alert on Undeclared Pecans, Walnuts, Milk and Soy in Good Sense Cranberries ‘N More
For Immediate Release
September 23, 2016
Contact
Announcement
View Product Photos
Waymouth Farms, Inc has initiated a voluntary recall of Good Sense® Cranberries ‘N More 6 oz (170g) with a Freshest if used by date of 8/16/2017 A 15:00 through Freshest if used by 8/16/2017 A 23:00 after discovering that inadvertently other allergens were packed into the Good Sense® Cranberries ‘N More package. Only 2640 packages were impacted. No other Good Sense® products are affected.
People who have an allergy or severe sensitivity to pecans, walnuts, wheat, milk and soy run the risk of serious or life-threatening allergic reaction if they consume this product. If you are a consumer and have purchased this product, please return the product to your retailer for a full refund or replacement.
Product Description: Good Sense® Cranberries ‘N More 6 oz (170g)
Freshest if Used by Date: Freshest if used by 8/16/17 A 15:00 through Freshest if used by 8/16/2017 A 23:00
The quality and safety of our products is the top priority for Waymouth Farms, Inc. We apologize to our retail customers and consumers and sincerely regret any inconvenience. We are working and cooperating fully with the U.S. Food and Drug Administration on this voluntary recall.
Distribution List For Recalled Chicken Nugget Products
in Pinching Pennies
Posted
http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-089-2016-release
News Release
Tyson Foods Inc. Recalls Chicken Nugget Products Due To Possible Foreign Matter Contamination
Class I Recall
089-2016
Health Risk: High
Sep 27, 2016
Distribution List PDF
http://www.fsis.usda.gov/wps/wcm/connect/da3bbfb1-ea69-4c74-bd76-f6a899fe8b8f/RC-089-2016-Retail-List.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=da3bbfb1-ea69-4c74-bd76-f6a899fe8b8f
Congressional and Public Affairs
Maria Machuca
(202) 720-9113
Press@fsis.usda.gov
WASHINGTON, Sept. 27, 2016 – Tyson Foods Inc., a Sedalia, Mo. establishment, is recalling approximately 132,520 pounds of fully cooked chicken nugget products that may be contaminated with hard plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The fully cooked Panko Chicken Nuggets items were produced on July 18, 2016. The following products are subject to recall:
View Labels PDF Only
http://www.fsis.usda.gov/wps/wcm/connect/0a5d70c0-467e-4d5b-be6b-ff0b14d93170/089-2016-labels.pdf?MOD=AJPERES
5-lb. bag containing “Tyson FULLY COOKED PANKO CHICKEN NUGGETS” with a “Best If Used By” date of July 18, 2017 and case code 2006SDL03 and 2006SDL33.
20-lb. bulk packages containing “SPARE TIME Fully Cooked, Panko Chicken Nuggets, Nugget Shaped Chicken Breast Pattie Fritters With Rib Meat” with a production date of July 18, 2016 and case code 2006SDL03.
The products subject to recall bear establishment number “EST. 13556” printed adjacent to the “Best If Used By” date on the back of the package. The 20-pound cases were shipped for institutional use in Pennsylvania and the five-pound bags were shipped to retail locations nationally.
The problem was discovered after the firm received consumer complaints regarding foreign material contamination of chicken nugget products. According to Tyson Foods, the plastic material ranged in size from 21mm in length and 6.5mm in diameter and may have come from a round, hard plastic rod used to connect a plastic transfer belt. The firm said the products pass through a metal detector, but the plastic is not detectable to this technology.
There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Consumers with questions about the recall can contact Tyson Foods’ Consumer Relations at (866) 328-3156. Media with questions about the recall can contact Worth Sparkman-Public Relations, Corporate Affairs, at (479) 290-6358.
John