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WormGuy

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  1. http://www.fda.gov/Safety/Recalls/ucm519741.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    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.

     

    Voluntary Recall of Whole Wheat Flour Product Due to Possible Foreign Matter

     

    For Immediate Release

    September 8, 2016

     

    Contact

    Consumers

    Customer Service Center

    customerservice@chg.com

    1-800-847-5608

     

    Announcement

    View Product Photos

    http://www.fda.gov/Safety/Recalls/ucm519741.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-photos

     

    Denton, Texas – The Morrison Milling Company has initiated a recall of the following item:

     

    Morrison’s Number

    Product Name

    Package Size

    Product UPC

    Product Lot Number

     

    01100

    The Baker’s Scoop HEB 100% Whole Wheat Flour

    Net Wt. 5 Lbs. (2.27Kg)

    4122019322

    Best By 021418 DIT 6236

    Best By 021518 DIT 6237

     

    Due the possibility of the presence of soft nylon fragments of mesh resembling white hair, caused by a faulty screen at our production facility. Foodborne foreign objects, in some instances may cause injuries such as choking. The severity and type of injury a consumer might experience depends on the size and shape of the foreign object.

     

    The problem was detected internally by our quality department during a routine production line check.

     

    There have been no consumer complaints, illnesses or injuries reported to date associated with this incident. While no nylon “hairs” have been found in finished product at all, we are taking this voluntary action in an overabundance of caution.

     

    The potentially affected products are distributed through retail HEB supermarkets which are located in the Southwestern region of the USA.

     

    The potentially affected product consists of retail packages weighing 5 Lbs.

     

    The code date information can be found on the top folded seal of the package.

     

    The Morrison Milling Company is committed to providing high-quality products, and the safety and satisfaction of our consumers is the company’s utmost priority.

     

    Consumers who have purchased the product with the above “Best By” dates before September 8, 2016 can return it to its place of purchase for a full refund. Consumers with questions may call our Customer Service Center at 1-800-847-5608 or by e-mail at customerservice@chg.com for more information. Our customer service desk will be staffed in person from 8am to 5pm CST Monday to Friday.

     

     

     

    :wormie2:

    John

  2. http://www.cpsc.gov/en/Recalls/2016/Toys-R-Us-Recalls-Pacifier-Clips/

     

     

    Toys ‘R’ Us Recalls Pacifier Clips Due to Choking Hazard; Sold Exclusively at Babies ‘R’ Us and Toys ‘R’ Us

     

    Recall date: SEPTEMBER 08, 2016

    Recall number: 16-259

     

    Recall Summary

    Name of product: Babies ‘R’ Us pacifier clips

     

    Hazard: The pacifier clip’s spring mechanism can break and release small parts, posing a choking hazard.

     

    Consumer Contact:

    Toys ‘R’ Us at 800-869-7787 from 9 a.m. to 5 p.m. ET Monday through Friday, or online at www.toysrus.com and click on Product Recalls for more information.

     

    Recall Details

     

    Units

    About 53,000

     

    Description

    This recall involves Babies‘R’Us pacifier clips sold in an assortment of six colors and character designs, including a red monster, blue monster, monkey, giraffe, owl with one eye closed, and an owl with both eyes open. The pacifier clips have a circular plastic cover affixed to a metal spring clip and a fabric strip with snaps at the other end. The recalled pacifier clip assortment has model number 5F6237F and “®2014 Geoffrey, LLC” engraved on the back to the plastic cover.

     

    Incidents/Injuries

    The firm has received two reports of pacifier clips breaking. No injuries have been reported.

     

    Remedy

    Consumers should immediately take the recalled pacifier clips from babies and return the product to Babies ‘R’ Us or Toys ‘R’ Us for a refund.

     

    Sold exclusively at

    Babies‘R’Us and Toy’R’Us stores nationwide from February 2015 through April 2016 for about $4.

     

    Importer(s)

    Toys ‘R’ Us Inc., of Wayne, N.J.

     

    Distributor(s)

    Toys ‘R’ Us Inc., of Wayne, N.J.

     

    Manufactured in

    China

     

     

     

    :wormie2:

    John

  3. http://www.cpsc.gov/en/Recalls/2016/HAUS-Mosquito-Zapper-LED-Light-Bulbs-Recalled-by-Creative-Sourcing/

     

     

    HAUS Mosquito Zapper LED Light Bulbs Recalled by Creative Sourcing Due to Shock Hazard

     

    Recall date: SEPTEMBER 08, 2016

    Recall number: 16-258

     

    Recall Summary

    Name of product: ZapBulb mosquito zapper LED light bulbs

     

    Hazard: The light bulb’s base can separate from the connector, posing an electrical shock hazard.

     

    Consumer Contact:

    Creative Sourcing International/Haus toll-free at 888-521-8326 from 8:30 a.m. to 5 p.m. ET Monday through Friday, email at hauswares@kalorik.com, or online at www.hauswares.com and click on Recall Information for more information.

     

    Recall Details

     

    Units

    About 11,500

     

    Description

    This recall involves the HAUS ZapBulb 2-in-1 mosquito zapper LED light bulbs. The 10-watt bulb has a white grid housing that measures about 3.1 inches high, 3.1 inches wide and 6.1 inches deep. The grid housing has a blue light used to attract insects and an LED light below, for lighting. Only units without any markings or labels are included in this recall. SKU number IK 3000 is on the product’s packaging.

     

    Incidents/Injuries

    The firm has received two reports of the bulb separating from the connector. No injuries or property damage have been reported.

     

    Remedy

    Consumers should immediately stop using the recalled light bulbs, turn off the power supply and contact Creative Sourcing for a free replacement mosquito zapper LED light bulb, including shipping, and instructions for removing and replacing the light bulb. Creative Sourcing will reimburse consumers if a professional electrician is needed to remove the recalled light bulb’s base.

     

    Sold at

    Online at Amazon, Groupon, Hammacher Schlemmer, Pulse TV, Sharper Image, Sportsman and Universal Direct from April 2016 through July 2016 for about $30.

     

    Manufacturer(s)

    HAUS, of Germany

     

    Importer(s)

    Creative Sourcing International, Inc., of Miami, Fla.

     

    Distributor(s)

    Creative Sourcing International, Inc., of Miami, Fla.

     

    Manufactured in

    China

     

     

     

    :wormie2:

    John

  4. Family Care Eye Wash by United Exchange Corp: Recall - Microbial Contamination

    AUDIENCE: Consumers, Eye Care, Pharmacy

     

    ISSUE: United Exchange Corp. is voluntarily recalling specific lots of Family Care Eye Wash 4 oz due to microbial contamination. These products consist of a purified water solution. Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight threatening eye infection.

     

    See the Press Release for a list of affected Lot numbers.

    http://www.fda.gov/Safety/Recalls/ucm519583.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

    BACKGROUND: Eye Wash/Eye Irrigation Solution is used to flush the eye to relieve irritation, stinging, or itching by removing foreign material such as air pollutants or chlorinated water. It is packaged in 4 oz (118mL) bottles. Family Care Eye Wash was distributed nationwide to wholesale and retail facilities.

     

    RECOMMENDATION: United Exchange Corp. is notifying its distributors and customers by recall letter and is arranging for return or disposal of all recalled products. Consumers and businesses that have product which is being recalled should stop using and selling them immediately.

     

    Consumers with questions regarding this recall should contact the Customer Service Department at 800-814-8028, available Monday through Friday from 8:30 am to 5:30 pm (Pacific Time). Consumers can contact their physician or healthcare provider if they have additional questions about this product.

     

    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 alert, including a link to the press release, at:

    http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm519602.htm

     

     

     

    :wormie2:

    John

  5. Eye Wash/Eye Irrigating Solutions Distributed by Major Pharmaceuticals and Rugby Laboratories: Recall - Microbial Contamination

     

    AUDIENCE: Consumers, Eye Care, Pharmacy

     

    ISSUE: United Exchange Corp. of Cerritos, CA, a primary source vendor of the Rugby-branded Eye Irrigating Solution and Major-branded Eye Wash, is voluntarily recalling products due to microbial contamination. These products consist of a purified water solution. Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight-threatening eye infection.

     

    BACKGROUND: Eye Wash/Eye Irrigating Solution is used to flush the eye to relieve irritation, stinging, or itching by removing foreign material such as air pollutants or chlorinated water. It is packaged in 4 oz (118mL) bottles. Rugby-branded Eye Irrigating Solution and Major-branded Eye Wash were distributed nationwide to wholesale and retail facilities including hospitals and pharmacies. The company learned of the potential issue through the receipt of a product complaint regarding this product. For a table of affected lots and expiration dates please see firm press release.

     

    RECOMMENDATION: Consumers, pharmacies, and healthcare facilities that have product which is being recalled should stop using and dispensing them immediately.

     

    Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these devices to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

     

    Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

    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 Firm Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm519570.htm

     

     

     

    :wormie2:

    John

  6. http://www.fda.gov/Safety/Recalls/ucm519531.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    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.

     

    Island Soups Company, Inc. Recalls Six Varieties of Island Soups Brand Products Because of Possible Contamination With Clostridium Botulinum

     

    For Immediate Release

    September 7, 2016

     

    Contact

    Consumers

    Island Soups Company, Inc.

    (917) 991-6647

     

    Announcement

    View Product Photos

    http://www.fda.gov/Safety/Recalls/ucm519531.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-photos

     

    Island Soups Company, Inc. of Saint Albans, New York is recalling the following products because they have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use these products.

     

    GUNGO PEAS SOUP, NET WT. 16OZ

     

    GUNGO PEAS SOUP NO MEAT, NET WT. 16OZ

     

    RED PEAS SOUP, NET WT. 16OZ

     

    RED PEAS SOUP NO MEAT, NET WT. 16OZ

     

    MANNISH WATER, NET WT. 16OZ

     

    FISH SOUP, NET WT. 16OZ

     

    All products are coded BEST BEFORE dates July 2015 through June 2018

     

    Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double- vision, and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.

     

    Products were distributed through internet website purchases.

     

    The products are packaged in 16 oz. glass jars with white lids and a white plastic with brown lettering safety seal.

     

    To date there have been no confirmed reports of illness and injury related to these products.

     

    FDA inspection of the establishment reveals that the firm does not have valid process schedules or process documentation to ensure that these soups products have been sufficiently processed to prevent the growth of Clostridium botulinum.

     

    Consumers should segregate and destroy any of the identified products.

     

    Consumers with questions can call 917-991-6647, Monday through Friday, 8:30 am – 4:30 pm, EST

     

     

     

    :wormie2:

    John

  7. FDA recently approved changes to the SUSTIVA (efavirenz) product labeling to include a new Warnings and Precautions regarding QTc prolongation. The following main changes to the product labeling were made:

     

    The following sub-section was added in the WARNINGS AND PRECAUTIONS section.

     

    5.2 QTc Prolongation: QTc prolongation has been observed with the use of efavirenz [see Drug Interactions (7.3, 7.4) and Clinical Pharmacology (12.2)]. Consider alternatives to SUSTIVA when co-administered with a drug with a known risk of Torsade de Pointes or when administered to patients at higher risk of Torsade de Pointes.

     

     

    The following new sub-section was added in the DRUG INTERACTIONS section.

     

    7.3 QT Prolonging Drugs: There is limited information available on the potential for a pharmacodynamic interaction between SUSTIVA and drugs that prolong the QTc interval. QTc prolongation has been observed with the use of efavirenz [see Clinical Pharmacology (12.2)]. Consider alternatives to SUSTIVA when co-administered with a drug with a known risk of Torsade de Pointes.

     

    Revisions were made in Table 5 and subsection 7.5 for Drugs Without Clinically Significant Interactions with SUSTIVA.

     

    Specifically the clinical comment for Anti-infective: Clarithromycin now states: Consider alternatives to macrolide antibiotics because of the risk of QT interval prolongation. Likewise for Antimalarials: Artemether/lumefantrine the clinical comment states: Consider alternatives to artemether/ lumefantrine because of the risk of QT interval prolongation.

     

     

    The following new sub-section was added in the Clinical Pharmacology section.

     

    12.2 Pharmacodynamics-Cardiac Electrophysiology: The effect of SUSTIVA on the QTc interval was evaluated in an open-label, positive and placebo controlled, fixed single sequence 3-period, 3-treatment crossover QT study in 58 healthy subjects enriched for CYP2B6 polymorphisms. The mean Cmax of efavirenz in subjects with CYP2B6 *6/*6 genotype following the administration of 600 mg daily dose for 14 days was 2.25-fold the mean Cmax observed in subjects with CYP2B6 *1/*1 genotype. A positive relationship between efavirenz concentration and QTc prolongation was observed. Based on the concentration-QTc relationship, the mean QTc prolongation and its upper bound 90% confidence interval are 8.7 ms and 11.3 ms in subjects with CYP2B6*6/*6 genotype following the administration of 600 mg daily dose for 14 days [see Warnings and Precautions (5.2)].

     

    You can view the updated label at Drugs@fda or DailyMed

     

    Steve Morin

    Office of Health and Constituent Affairs

    Food and Drug Administration

     

    Kimberly Struble

    Division of Antiviral Products

    Food and Drug Administration

     

    Richard Klein

    Office of Health and Constituent Affairs

    Food and Drug Administration

     

    For more information about the HIV Liaison Program

    http://www.fda.gov/ForPatients/Illness/HIVAIDS/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelive

     

    visit the FDA Patient Network

    http://www.fda.gov/ForPatients/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

     

    :wormie2:

    John

  8. Recently, FDA approved changes to the GENVOYA (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide), 150/150/200/10 mg fixed-dose combination tablet product labeling. The following main updates were made:

     

    1. Longer term safety, efficacy and resistance data from 96 weeks of treatment from Study GS-US-292 0104 & GS-US-292 0111 (antiretroviral therapy (ART)-naive adults).

     

    GS-US-292-0104 entitled “A Phase 3, Randomized, Double-Blind Study to EvaluateThe Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1Positive, Antiretroviral Treatment- Naïve Adults”

     

    GS-US-292-0111 entitled “A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment- Naïve Adults”

     

    2. Drug-drug interactions between Genvoya and the following co-administrated drugs in healthy subjects 1) ledipasvir/sofosbuvir fixed-dose combination tablet; and 2) sofosbuvir/velpatasvir fixed-dose combination tablet. No clinically significant drug interactions were observed when GENVOYA is combined with ledipasvir or velpatasvir.

     

    3. In addition, the content of labeling was updated to include content and format revisions to the “Use in Specific Populations (Sections 8.1 and 8.2)” related to the Pregnancy and Lactation Labeling Rule (PLLR).

     

    The updated label will soon be available drugs@fda

    https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

     

    or DailyMed

    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=34784acf-15ed-4715-b504-eb30430518e9&source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    Steve Morin

    Office of Health and Constituent Affairs

    Food and Drug Administration

     

    Kimberly Struble

    Division of Antiviral Products

    Food and Drug Administration

     

    Richard Klein

    Office of Health and Constituent Affairs

    Food and Drug Administration

     

    For more information about the HIV Liaison Program visit the FDA Patient Network

    http://www.fda.gov/ForPatients/Illness/HIVAIDS/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

    visit the FDA Patient Network

    http://www.fda.gov/ForPatients/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

     

    :wormie2:

    John

  9. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm519540.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    Ovarian Cancer Screening Tests: Safety Communication - FDA Recommends Against Use

     

    Posted 09/07/2016

    AUDIENCE: Patient, OBGYN, Oncology

     

    ISSUE: The FDA is alerting women about the risks associated with the use of tests being marketed as ovarian cancer screening tests. The Agency is especially concerned about delaying effective preventive treatments for women who show no symptoms, but who are still at increased risk for developing ovarian cancer.

     

    Despite extensive research and published studies, there are currently no screening tests for ovarian cancer that are sensitive enough to reliably screen for ovarian cancer without a high number of inaccurate results. However, over the years, numerous companies have marketed tests that claim to screen for and detect ovarian cancer.

     

    FDA is concerned that women and their physicians may be misled by such claims and rely on inaccurate results to make treatment decisions. Based on the FDA’s review of available clinical data from ovarian cancer screening trials and recommendations from healthcare professional societies and the U.S. Preventive Services Task Force, available data do not demonstrate that currently available ovarian cancer screening tests are accurate and reliable in screening asymptomatic women for early ovarian cancer. For example, some women may receive test results that suggest ovarian cancer even though no cancer is present (a false-positive). These women may undergo additional medical tests and/or unnecessary surgery, and may experience complications related to both. Or, test results may not show ovarian cancer even though cancer is present (a false-negative), which may lead women to delay or not seek surgery or other treatments for ovarian cancer.

     

    Using unproven ovarian cancer screening tests also may be harmful for women with increased risk for developing ovarian cancer. For instance, these women and their doctors may not take appropriate actions to reduce their future risk if they rely on a result that shows no cancer currently present. Yet, this group of women is still at high risk of developing ovarian cancer later based on their gene mutation and/or family history. The FDA believes that women at high risk for developing ovarian cancer should not use any currently offered test that claims to screen for ovarian cancer.

     

    BACKGROUND: Ovarian cancer occurs when abnormal cells in or near the ovaries grow and form a malignant (cancerous) tumor. In the United States, ovarian cancer is the fifth leading cause of cancer-related death among women. The National Cancer Institute estimates that in 2016, more than 22,000 women will be diagnosed with ovarian cancer. Women who have reached menopause, women who have a family history of ovarian cancer, and women with the BRCA1 or BRCA2 genetic mutations have the highest risk for developing ovarian cancer.

     

    RECOMMENDATION: Based on currently available information, the FDA recommends against using currently offered tests to screen for ovarian cancer.

     

    For women, including those at increased risk of developing ovarian cancer:

     

    Be aware that there is currently no safe and effective ovarian cancer screening test.

    Do not rely on ovarian cancer screening test results to make health or treatment decisions.

    Talk to your doctor about ways to reduce your risk of developing ovarian cancer, especially if you have a family history of ovarian cancer, or have the BRCA1 or BRCA2 genetic mutations.

     

    For physicians:

    Do not recommend or use tests that claim to screen for ovarian cancer in the general population of women. Be aware that testing higher risk asymptomatic patients for ovarian cancer has no proven benefit and is not a substitute for preventive actions that may reduce their risk.

    Consider referring women at high risk of developing ovarian cancer, including those with BRCA mutations, to a genetic counselor or gynecologic oncologist, or other appropriate health care provider for more specialized care.

     

     

     

    :wormie2:

    John

  10. http://www.fda.gov/Safety/Recalls/ucm519371.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    Company Announcement

    FDA posts press releases and other notices of recalls and safety alerts from states as a service to consumers, the media, and other interested parties. FDA is not responsible for the content of these notices.

     

    DATCP Issues Consumer Advisory for Cottage Cheese Produced By Westby Cooperative Creamery

     

    For Immediate Release

    August 26, 2016

     

    Contact

    Consumers

    Division of Food and

    Recreational Safety

    datcpfood@wisconsin.gov

    608-224-4700

     

    Media

    Raechelle Belli

    608-224-5005

    Bill Cosh

    608-224-5020

     

    Announcement

    MADISON, Wisconsin — The Wisconsin Department of Agriculture, Trade and Consumer Protection (DATCP) – Division of Food and Recreational Safety is issuing a consumer alert for 4% cottage cheese made by Westby Cooperative Creamery located in Westby, Wisconsin. The presence of active alkaline phosphatase was discovered in samples during routine testing and may indicate that the product was not adequately pasteurized.

     

    Alkaline phosphatase is an enzyme naturally present and active in raw milk that is not active in milk that has been sufficiently pasteurized. Raw milk can be contaminated by pathogenic bacteria like E. coli O157, Salmonella, Campylobacter and Listeria. If these pathogens were present in the raw milk that was inadequately pasteurized, they may have survived and, if ingested, could cause illness. No illnesses have been reported related to consumption of this product and no other Westby Cooperative Creamery products are included in this advisory.

     

    Nearly 700 cases of product were distributed statewide in Wisconsin and to Aurora, Illinois. Consumers should only be concerned with cottage cheese sold on or before August 26, 2016 in 16-, 22- and 24-ounce containers under the Westby, Food Club, Oberweis and Shurfine brand names. The containers will contain lot code 10-6-16 cc. Consumers in possession of this product should not consume it, but should return it to the place of purchase or discard it.

     

    Symptoms of foodborne illness are diarrhea and/or vomiting, typically lasting 1-7 days. Other symptoms might include abdominal cramps, nausea, fever, joint/back aches and fatigue. If you have consumed this product and think you may be ill, contact your physician immediately.

     

    For more information on other food product advisories or recalls, contact the Division of Food and Recreational Safety at 608-224-4700, by e-mail at datcpfood@wisconsin.gov; or online at datcp.wi.gov.

     

     

     

    :wormie2:

    John

  11. http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Reports/ucm519254.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    Mammography Facility Adverse Event and Action Report - September 6, 2016: AdvancedTech Breast Imaging Specialists, LLC

     

    Background

    As part of the Mammography Quality Standards Act (MQSA), Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and that it should include information that is useful in evaluating the performance of mammography facilities nationwide. In order to provide this information in the timeliest manner, we now post the following information in “real time,” as actions taken against mammography facilities are concluded:

     

    Mammography Facility Against Which There Was An Adverse Action

     

    The State of Illinois

    Facility Name and Address:

    AdvancedTech Breast Imaging Specialist, LLC

    500 N Maple Street

    Effingham, IL 62401

    Facility ID Number:

    238268

     

    Adverse Event:

    As a condition of reaccreditation of this facility, the State of Illinois Certification Agency (SIL CA) requested that the facility’s accreditation body, the American College of Radiolgy (ACR), conduct a Full Additional Mammography Review (AMR). The additional images above the number usually required for accreditation were required because the facility previously failed an AMR which resulted in a State of Illinois directed Patient and Physician Notification (PPN).

     

    On April 20, 2016, the ACR informed the facility that mammograms reviewed during the AMR did not meet the ACR’s criteria for clinical image quality and that it believed the deficiencies posed a serious risk to human health.

     

    Action Taken:

    The ACR revoked the facility’s accreditation which caused the provisional certificate issued by SIL CA to expire, effective April 29, 2016.

     

    Corrective Action:

    On May 9, 2016, the SICA required the facility to perform another PPN to alert all at-risk patients and their providers of the mammography quality problems at the facility.

    The facility successfully completed the second PPN and was notified of such by the SIL CA on June 29, 2016.

     

    Status of the Facility:

    The facility is no longer performing mammography.

     

  12. http://www.fda.gov/Safety/Recalls/ucm519248.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    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.

     

    Kanan Enterprises Conducts Voluntary Recall of Cashews with Sea Salt

     

    For Immediate Release

    September 3, 2016

     

    Contact

    Consumers

    1-800-860-5464

     

    Announcement

    Solon, OH — Kanan Enterprises announces the voluntary recall of Southern Grove Cashews with Sea Salt due to possible presence of peanuts. People who have an allergy to peanuts run the risk of a serious or life-threatening allergic reaction if they consume these products. No adverse reactions have been reported associated with this recall.

     

    The only item that is affected by this recall is Southern Grove Cashews With Sea Salt, a 10 ounce stand up pouch bag with a UPC 0 41498 18992 1 and a date code of Best By May 24 2017 KN and Best By AUG 05 2017 KN. No other products or date codes are affected. We shipped this product to Ohio and Kansas. Our customer shipped some of the product to Minnesota.

     

    Consumers with this reported product should not consume this product. They should destroy it or return the product to the point of purchase. Consumers with questions should call 1-800-860-5464, 8:15 am – 5:00pm EST, Monday – Friday.

     

     

     

    :wormie2:

    John

  13. http://www.fda.gov/Safety/Recalls/ucm519174.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    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.

     

    Kinetic Technologies and Kinetic Vet Announce the Voluntary Nationwide Recall of Hy-Optic, OptiVet and Optimend Due to Deficiencies in Sterility

     

    For Immediate Release

    September 2, 2016

     

    Contact

    Consumers

    Customer Service

    877-786-9882

     

    Media

    Justin Banks

    859-258-9160

     

    Announcement

    Kinetic Technologies and Kinetic Vet located in Lexington, KY has voluntarily recalled Hy-Optic – lot # 10092015, OptiVet – lot # 12032015 and Optimend – lot # 01122015. This voluntary recall is the result of deficiencies in sterility, which may lead to deteriorating eye conditions, irritation and/or infection.

     

    Hy-Optic Eye Irrigating Solution – NDC # 51031-011-15, Lot # 10092015, Exp. Date 10/2017

    OptiVet Eye Irrigating Solution –- NDC # 51031-011-15, Lot # 12032015, Exp. Date 07/2017

    Optimend Corneal Repair Drops – NDC # 51031-013-10, Lot # 01122015, Exp. Date 10/2017

     

    Each product is packaged in a branded box with the lot number and expiration date printed on the box. Hy-Optic Eye Irrigating Solution and OptiVet Eye Irrigating Solution are packaged in 15 mL oval eye drop containers and labeled prior to packaging. No animal species are listed on the label for use in non-specified animals. Optimend Corneal Repair Drops is packaged in a 10 mL circular eye drop container and labeled prior to packaging for use in dogs, cats and horses for the treatment of corneal ulcers.

     

    The recalled products were distributed over-the-counter (OTC) nationwide through retail stores and through distributors by veterinarians for clinic use and dispensing to their patients.

     

    Bacteria were detected in some of the samples. The product’s lack of sterility can lead to deteriorating eye conditions, irritation and/or infection and potentially, loss of sight.

     

    To date, the company has not received adverse event reports attributable to the contamination of any of these products.

     

    As a safety precaution the company is conducting a voluntary recall and will continue to closely monitor for reports of adverse drug reactions and product complaints.

     

    The U.S. Food and Drug Administration is aware of this recall. Notification of the recall has been sent to distributors.

     

    Consumers who have purchased Hy-Optic, OptiVet and Optimend should stop using the product(s) at once and may return product(s) to the place of purchase for a full refund. If the treated eye is unimproved or the condition has worsened, owners should consult with a veterinarian for further diagnosis and appropriate treatment. Untreated eye conditions may result in pain and potential loss of eyesight. Vision loss which is complete or partial and temporary or permanent. Consumers with questions or adverse events to report may contact the company at 1-877-786-9882 M-F 8:30 am – 5:00 pm. Adverse events associated with these, or other products for use in animals, may also be reported directly to the FDA by following information provided here: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm

     

     

     

    :wormie2:

    John

  14. http://www.fda.gov/Safety/Recalls/ucm519188.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    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.

     

    Asher's Chocolates/Lewistown, Inc. Issues Voluntary Recall of Candy Products Because of Possible Health Risk

     

    For Immediate Release

    September 2, 2016

     

    Contact

    Consumers

    Customer Service

    customerservice@lewistownashers.com

    888-288-3880

     

    Media

    Jeff Asher

    888-288-3880

     

    Announcement

    View Product Photos

    http://www.fda.gov/Safety/Recalls/ucm519188.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-photos

     

    Asher’s Chocolates/Lewistown, Inc., an affiliated partner of Chester A. Asher Inc. (“Asher’s”) is initiating a voluntary recall of multiple chocolates, chocolate bars, cellophane wrapped chocolates, and individually wrapped chocolates, etc. under the Asher’s brand due to possible Salmonella contamination of items produced in their Lewistown, PA facility distributed nationwide.

     

    Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

     

    Asher’s Brand Products under this voluntary recall are:

     

    Product UPC

    Label Description

    Lot#

    Size

     

    11516

    Milk Chocolate Pretzel Pieces 8 oz.

    000334469

    8 oz.

     

    11517

    Dark Chocolate Pretzel Pieces 8 oz.

    000334470

    8 oz.

     

    14765

    Milk Chocolate Vanilla Caramel with Sea Salt 4 oz.

    000337556

    4 oz.

     

    47350

    Dark Chocolate Hostess Mint 6 oz.

    000335615

    6oz.

     

    55115

    KEYSTONE CRUNCH 4 OZ BAG

    000336374, 000337658

    4 oz.

     

    55165

    KEYSTONE CRUNCH 6 oz.

    000335591

    6 oz.

     

    55180

    Milk Chocolate Coated Boardwalk Crunch 4 oz.

    000335625

    4 oz.

     

    55185

    KEYSTONE CRUNCH 1 LB

    000336375

    16 oz.

     

    63385

    Milk Chocolate with Fall String 4 oz.

    000335852

    4 oz.

     

    63386

    Dark Chocolate mini Pretzels Fall String 4 oz.

    000335848

    4 oz.

     

    65902

    Dark Chocolate Molasses Pop 4 oz.

    000336201, 000335800

    4 oz.

     

    65902

    Dark Chocolate Molasses Pop 2 oz.

    000336376

    2 oz.

     

    67395

    Milk Chocolate Peanut Butter Heaven 3 oz.

    000337016, 000337663

    3 oz.

     

    75005

    Milk Chocolate Nonpareil Pop 1.25 oz.

    000335701, 000336520

    1.25 oz.

     

    75027

    Milk Chocolate Crisped Rice Pop with Fall Leaves 3 oz.

    000337574, 000337673

    3 oz.

     

    75030

    Milk Chocolate Crisped Rice Pop with Christmas Seeds 3 oz.

    000336521

    3 oz.

     

    75037

    Milk Chocolate Crisped Rice Pop Multi Seeds 2.25 oz.

    000335803, 000337173

    2.25 oz.

     

    75085

    Milk Chocolate Non Peril with Fall Seed 4 oz.

    000335963

    4 oz.

     

    75086

    Dark Chocolate Non Pareils with Fall Seed 4 oz.

    000335858

    4 oz.

     

    75087

    White Confectionery Coating Non pareils with orange and yellow seed 4 oz.

    000337178

    4 oz.

     

    75107

    White Confectionery Coating Peanut Butter Cup 2.35 oz.

    000336377, 000337560, 000337665

    2.35 oz.

     

    75141

    Milk Chocolate POTATO CHIP 4 oz.

    000335918

    4 oz.

     

    75151

    Milk Chocolate Coated Mini Pretzels 4 oz.

    000335843, 000336481

    4 oz.

     

    75152

    Dark Chocolate Coated Mini Pretzels 4 oz.

    000335590, 000336482

    4 oz.

     

    75153

    White Confectionery Coated Mini Pretzels 4 oz.

    000335589

    4 oz.

     

    75245

    Milk Chocolate Pretzel Rod 3pcs Asst. with Asher Bow 3.5 oz.

    000335802, 000335910, 000336608, 000337177

    3.5 oz.

     

    75260

    Milk Pretzel Rod 3 piece assorted 3.5 oz.

    000335699, 000337664

    3.5 oz.

     

    75261

    Milk Chocolate Pretzel Cluster 4 oz.

    000335930, 000336198, 000336378, 000336879, 000337013

    4 oz.

     

    75277

    Milk Chocolate Coated Potato Chip Coffee Bag 8.5 oz.

    000336044

    8.5 oz,

     

    75279

    Milk Boardwalk Crunch Coffee Bag 6 oz.

    000335043

    6 oz.

     

    75282

    Dark Chocolate costed POTATO CHIP COFFEE BAG 8.5 oz.

    000335851

    8.5 oz.

     

    76025

    Milk Chocolate Crisped Rice Pop Multi Seeds 3 oz.

    000335722, 000337573, 000335462

    3 oz.

     

    82379

    Milk SF Almond Butter Toffee 3 oz.

    000335955

    3 oz.

     

    82421

    Milk Chocolate Fruit Center Bar 3.5 oz.

    000335414

    3.5 oz.

     

    83851

    Dark Chocolate Almond Bark (Scored) 4 oz.

    000335647, 000335856

    4 oz.

     

    83855

    Milk Chocolate Non Pareils with multi seed 4 oz.

    000335854

    4 oz.

     

    83856

    Dark Chocolate Non Pareils with White Seed 4 oz.

    000335855

    4 oz.

     

    83858

    Milk Chocolate Mini Pretzels 4 oz.

    000335588

    4 oz.

     

    83859

    Dark Chocolate Mini Pretzel Ash Label 4 oz.

    000335862

    4 oz.

     

    83860

    White Confectionery Coated Mini Pretzels 4 oz.

    000335969, 000337245

    4 oz.

     

    87145

    Milk and Dark Chocolate Fall Pretzel Pre Pack 3 per case

    000336450

    4 oz.

     

    The recalled items can be identified by the production code printed on the side of the label. No other production codes are affected by this recall.

     

    No illnesses have been reported to date in connection with this problem. No products manufactured by C.A. Asher Inc./Asher’s Chocolate Co. of Souderton PA are involved in this recall.

     

    The recalled candy products were distributed nationwide in retail stores.

     

    The potential for contamination was noted after a single sample from routine testing by the company revealed the presence of Salmonella in a group of products. “The safety and wellbeing of our customers is our primary concern, and we are taking this incident very seriously. In our 124 years of business, we have never previously detected Salmonella in our testing. We are working and cooperating fully with the U. S. Food & Drug Administration on this voluntary recall,” said Jeff Asher, President and CEO. “We apologize to our retail customers and consumers and sincerely regret any inconvenience.”

     

    Consumers who may have purchased any product are urged not to consume it. Consumers should contact Customer Service to arrange for return of product and a refund. Customer Service can be contacted by email at customerservice@lewistownashers.com or by calling 888-288-3880 between 9AM and 5PM Eastern Time, Monday - Friday.

     

     

     

    :wormie2:

    John

  15. http://www.fda.gov/Safety/Recalls/ucm519172.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    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.

     

    Wegmans Announces Voluntary Recall for One Date Code of Wegmans Italian Classics Striped Ricotta & Spinach Ravioli, Which May Contain Pieces of White Plastic

     

    For Immediate Release

    September 2, 2016

     

    Contact

    Consumers

    Wegmans Consumer Affairs Dept

    1-855-934-3663

     

    Media

    Valerie Fox

    585-720-5713

     

    Announcement

    View Product Photos

    http://www.fda.gov/Safety/Recalls/ucm519172.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-photos

     

    ROCHESTER, N.Y. – Wegmans Food Markets, Inc. is voluntarily recalling one date code of Wegmans Italian Classics Striped Ricotta & Spinach Ravioli, 9 oz. (UPC # 0-77890-38934), sold between Tuesday, Aug. 2 and Tuesday, Aug. 30, 2016 because the product may contain pieces of white plastic. Only product labeled with a use or freeze by date of Sept. 30, 2016 is included in the recall. This product, produced by O’ Sole Mio in Quebec, Canada, is packaged in a plastic tray and sold in a refrigerated case in the dairy department.

     

    Approximately 1,638 units of Wegmans Italian Classics Striped Ricotta & Spinach Ravioli, 9 oz. were sold in 90 Wegmans stores located in New York, New Jersey, Pennsylvania, Virginia, Maryland, and Massachusetts. Wegmans reports that all product with the affected code date is no longer on store shelves.

     

    There have been no injuries reported to date associated with this product.

     

    The recall was initiated because Wegmans was notified by customers that white plastic pieces were found in the product. Wegmans will place automated phone calls to customers who purchased the product using their Shoppers Club card.

     

    Customers who purchased the recalled product from Wegmans should return it to the service desk for a full refund. Consumers with questions may contact Wegmans Consumer Affairs Department toll free at 1-855-934-3663 Monday through Friday, between 8:00 a.m. and 5:00 p.m. Eastern time.

     

    Wegmans Food Markets, Inc. is a 90-store supermarket chain with stores in New York, Pennsylvania, New Jersey, Virginia, Maryland, and Massachusetts. The family-owned company, recognized as an industry leader and innovator, is celebrating its 100th anniversary in 2016. Wegmans has been named one of the ‘100 Best Companies to Work For by FORTUNE magazine for 19 consecutive years, ranking #4 in 2016.

     

     

     

    :wormie2:

    John

  16. http://www.fda.gov/Safety/Recalls/ucm519169.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    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.

     

    Regalo Bakery Issues Allergy Alert On Undeclared Allergens In Bakery Products

     

    For Immediate Release

    September 2, 2016

     

    Contact

    Consumers

    Christian Nalumen

    808-524-8421

     

    Announcement

    Honolulu, Hawaii - Regalo Bakery is recalling the following products due to undeclared Eggs, Wheat, Milk, Soy, and Artificial Food Coloring: "Spanish Rolls", "Manju Blackbeans(Hopia Monggo)", Manju Onions(Hopia Baboy)", "Balintawak", and "Taro Bread". "Kababayan" contains no egg, but contains wheat, soy, and artificial food colorings. People who have an allergy or severe sensitivity to eggs, wheat, milk, soy and artificial food color (e.g. yellow #5, yellow #6, or red 40) run the risk of serious or life-threatening allergic reaction if they consume these products. For those who are susceptible to allergic reactions, allergens can cause hives, swelling, itchiness, cramps, difficulty swallowing, shortness of breath, diarrhea, and possibly anaphylaxis.

     

    During a routine Food and Drug Administration inspection, it was discovered that several labels of products containing Eggs, Wheat, Milk, Soy, and Artificial Food Coloring were not listed.

     

    There have been no reported illness to date. However, consumers, especially with the food allergies listed above, should monitor their health and immediately contact their healthcare provider if he or she feels any of the symptoms listed above after consuming the product(s).

     

    These products were distributed locally, and interisland to several grocery stores such as Foodland, Longs, Target, 7-Eleven, Don Quijote, and more.

     

    The following products subject to recall due to undeclared allergens are:

     

    "Spanish Rolls"[uPC#78253230919]: Packaged in a clear plastic bag, containing eight pieces, with a net weight of 14 ounces. This product contains: eggs, wheat, milk, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6)

     

    "Manju Blackbeans (Hopia Monggo)" [uPC#78253230917] and "Manju Onions (Hopia Baboy)" [uPC#78253230918]: Both packaged on a foam tray with six pieces each, wrapped in clear plastic film. This product contains: eggs, wheat, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6)

     

    "Balintawak" [uPC#78253203095] : Packaged on a foam tray, containing four pieces, wrapped in clear plastic film, and have a net weight of 16 ounces. This product contains: eggs, wheat, milk, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6).

     

    "Taro Bread" [uPC#78253231001] : Packaged in a clear plastic bag, containing twelve pieces, and have a net weight of 20 ounces This product contains This product contains: eggs, wheat, milk, soy, coconut, and artificial food coloring (Red 40 & 3, Yellow 5 & 6, Blue 1).

     

    "Kababayan" [uPC#78253230920]: Packaged on a foam tray, containing six pieces, and wrapped in a clear plastic film. This product contains This product contains wheat, milk, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6).

     

    Consumers with the food allergies listed above should immediately stop consuming the product(s) and may return any unconsumed, unexpired item(s) back to the place of purchase for a full refund.

     

    For further questions, consumers may contact the company at (808) 524-8421 on Sundays from 7am to 5pm, and Tuesdays to Thursdays from 7am to 4pm.

     

    We, here at Regalo Bakery, sincerely apologize for this serious health hazard, especially to those who were affected. Immediate efforts are being made to update the labels to be as detailed as possible to ensure the health, safety, and well-being of the consumers. We humbly ask you to forgive us and continue to support us in the future.

     

    Mahalo,

    Christian Nalumen, Sales Representative

     

     

     

    :wormie2:

    John

  17. http://www.cpsc.gov/en/Recalls/2016/Polaris-Recalls-RZR-XP-Turbo-Recreational-Off-Highway-Vehicles/

     

     

    Polaris Recalls RZR XP Turbo Recreational Off-Highway Vehicles Due to Fire Hazard; Severe Burn Injuries; Includes Previously Recalled RZR Turbo ROVs

     

    Recall date: SEPTEMBER 01, 2016

    Recall number: 16-257

     

    Recall Summary

    Name of product: Recreational Off-Highway Vehicles (ROVs)

     

    Hazard: The vehicles' engine can overheat and turbo system’s drain tube can loosen, posing a fire hazard.

     

    Consumer Contact:

    Polaris at 800-765-2747 from 7 a.m. to 7 p.m. CT Monday through Friday, or online at www.polaris.com and click on “Off-Road Safety Recalls” on the main page for more information.

     

    Recall Details

     

    Units

    About 13,000 (including the 2, 230 vehicles previously recalled on December 2015.)

     

    Description

    This recall involves all model year 2016 Polaris RZR XP Turbo and RZR XP 4 Turbo recreational off-highway vehicles. The ROVs were sold in blue, gray, orange and red and have two or four seats and a rear box. “RZR” is printed on the rear box or on the right and left rear fenders and “Turbo” on the hood or on the right and left front fenders. “Polaris” is stamped onto the front grill. All model and Vehicle Identification Numbers (VINs) are included in this recall.

    To check for recalled vehicles visit www.polaris.com.

     

    Incidents/Injuries

    Polaris has received 19 reports of the ROVs catching on fire, resulting in six reports of burn injuries. One of the reported fires occurred in Utah’s American Fork Canyon, which led to a young child suffering severe burns and 15 acres of forest land being destroyed.

     

    Remedy

    Consumers should immediately stop using the recalled ROVs and contact Polaris to schedule a free repair. Consumers will receive an extended warranty on each repaired RZR Turbo and a discount towards the purchase of a new vehicle.

     

    Sold at

    Polaris dealers nationwide from August 2015 through July 2016 for between $25,000 and $27,500.

     

    Importer(s)

    Polaris Industries Inc., of Medina, Minn.

     

    Distributor(s)

    Polaris Industries Inc., of Medina, Minn.

     

    Manufactured in

    U.S. and Mexico

     

     

     

    :wormie2:

    John

  18. Report on Regional FSMA Import Safety Meetings

     

    September 2, 2016

     

    The FDA held public meetings in June 2016

    http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm499066.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

    in three strategic regions (California, Michigan and New Jersey) on the implementation of import safety programs under the FDA Food Safety Modernization Act (FSMA), including the Foreign Supplier Verification Programs (FSVPs), Accredited Third-Party Certification, and the Voluntary Qualified Importer Program (VQIP).

     

    Today, the agency released a report on what importers and other interested parties had to say.

    http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm518902.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. The meetings were designed to assess the state of importer readiness, elicit feedback, ideas, and comments regarding FSMA programs, and identify training and outreach ideas that could be helpful in supporting industry compliance with FSVP requirements.

     

    After listening closely to 350 importers, food producers, and foreign and industry association representatives, and analyzing data, a number of themes from the participants’ responses emerged. These include:

     

    Members of industry want help in understanding what is required under the FSMA provisions, including clearer, concise information from the FDA.

    Small importers and food producers are at higher risk of failing to comply with FSVP.

    Importers will likely consider cost, return on investment and effort necessary to participant when deciding whether to sign up for VQIP, which will provide expedited clearance to qualified participants.

    Additional Information

     

    Report on Regional FSMA Import Safety Meetings

    http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm518848.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

     

    :wormie2:

    John

  19. The U.S. Food and Drug Administration today issued a final rule establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed. Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Some manufacturers have already started removing these ingredients from their products.

     

    This final rule

    https://www.federalregister.gov/articles/2016/09/06/2016-21337/safety-and-effectiveness-of-consumer-antiseptics-topical-antimicrobial-drug-products-for?source=govdelivery&utm_medium=email&utm_source=govdelivery

    applies to consumer antiseptic wash products containing one or more of 19 specific active ingredients, including the most commonly used ingredients – triclosan and triclocarban. These products are intended for use with water, and are rinsed off after use. This rule does not affect consumer hand “sanitizers” or wipes,

    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm509097.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

    or

    antibacterial products used in health care settings.

    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm445002.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

    To learn more, please visit: antibacterial soaps.

    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm517478.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

     

    :wormie2:

    John

  20. http://www.fda.gov/Safety/Recalls/ucm518957.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    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.

     

    Aura Cacia Voluntarily Recalls Milk & Oat Bath Products Due to Possible Health Risk

     

    For Immediate Release

    September 1, 2016

     

    Contact

    Consumers

    Frontier Co-op

    1-800-669-3275

     

    Media

    Anne Rierson

    anne.rierson@frontiercoop.com

    319-227-7996 ext. 1163

     

    Announcement

    Norway, Iowa - Frontier Co-op is initiating a voluntary recall for the following Aura Cacia Milk & Oat Bath products. Recalled products were sold online and in stores in all 50 states and in some parts of Canada to distributors, retailers and consumers.

     

    This voluntary recall is the result of FDA testing that revealed an elevated microorganism count in Aura Cacia Lavender Milk & Oat Bath. While cosmetic products are not required to be sterile, an elevated microorganism count indicates that the product could pose a hazard to health. To date, no illnesses have been associated with these products.

     

    UPC

    Description

    Recalled Lot

     

    0-51381-90307-7

    1.75 ounce packet Lavender Milk and Oat Bath

    5289

     

    0-51381-90317-6

    9.75 ounce jar Lavender Milk and Oat Bath

    5296

     

    0-51381-30307-5

    49.6g Lavender Milk and Oat Bath (Canadian Distribution Only)

    5281

     

    The location of the lot number for the 1.75 oz and 49.6g packets is embossed in the seam on the side of the packet. For the 9.75 oz jar, the lot number is printed on the back of the label or stickered on the bottom of the jar. Consumers can find photos of the recalled products at www.auracacia.com/recall.

    Frontier Co-op is initiating recall notices to our accounts that received any of the above recalled products with instructions for returning or destroying the recalled products and for notifying their customers of the recall.

     

    Please contact Frontier Co-op with any questions or to inquire about replacement or reimbursement at 1-800-669-3275 Monday through Friday from 8:00 a.m. to 5:00 p.m. Central time.

     

    Aura Cacia®

    Inspired by the power of positive change, Aura Cacia’s products are made from simple and pure botanical ingredients that unlock nature’s ability to improve our well-being. Each purchase of an Aura Cacia product supports organizations that help women transform their lives through the brand’s Positive Change Project. Aura Cacia is a brand of Frontier Co-op. Learn more at www.auracacia.com.

     

    Frontier Co-op™

    Founded in 1976 and based in Norway, Iowa, Frontier Co-op offers a full line of natural and organic products under the Frontier, Simply Organic® and Aura Cacia® brands. Products include culinary herbs, spices and baking flavors; bulk herbs and spices; and natural and organic aromatherapy products. Frontier Co-op's goal is to provide consumers with the highest-quality organic and natural products while supporting and promoting social and environmental responsibility. For more information, visit Frontier Co-op's website at www.frontiercoop.com.

     

     

     

    :wormie2:

    John

  21. http://www.cpsc.gov/en/Recalls/2016/KTM-North-America-Recalls-Motocross-Competition-Off-Road-Motorcycles/

     

     

    KTM North America Recalls Motocross Competition Off-Road Motorcycles Due to Crash Hazard

     

    Recall date: SEPTEMBER 01, 2016

    Recall number: 16-255

     

    Recall Summary

    Name of product: Motocross competition off-road motorcycles

     

    Hazard: The connecting rod in the crankshaft assembly can fracture, causing the operator to lose control of the motorcycle and crash.

     

    Consumer Contact:

    KTM North America/Husqvarna Motorcycles North America toll-free at 888-985-6090 from 8 a.m. to 5 p.m. ET Monday through Friday or online at www.ktmusa.com or www.husqvarna-motorcycles.com and click on “Service” and then “Safety” for more information.

     

    Recall Details

     

    Units

    About 920

     

    Description

    This recall involves model year 2016 KTM brand and Husqvarna Motorcycles brand motocross off-road motorcycles with 250cc, 4-cycle engines. Recalled KTM 250 SX-F motorcycles are orange and black with the KTM logo on both sides of the shrouds covering the fuel tank. The engine size is printed on both sides of the rear fender below the rear of the seat. Recalled KTM 250 SX-F Factory Edition motorcycles are orange and blue with the KTM and the Red Bull logos on both sides of the shrouds covering the fuel tank. The number “13” is printed on both sides of the rear fender below the rear of the seat. Recalled Husqvarna FC 250 motorcycles are white with blue and yellow markings. The Husqvarna logo and engine size are on both sides of the shrouds covering the fuel tank. Model year 2016 motorcycles have a letter “G” in the 10th position of the vehicle identification number (VIN), located on the right side of the steering head.

     

    Incidents/Injuries

    The firm has received five reports of the rod cracking. No injuries have been reported.

     

    Remedy

    Consumers should immediately stop using the recalled motorcycles and contact an authorized KTM or Husqvarna Motorcycles dealer to schedule a free repair.

     

    Sold at

    2016 KTM Motorcycles were sold at KTM authorized dealers nationwide from October 2015 through March 2016 for between $8,400 and $9,100. 2016 Husqvarna Motorcycles were sold at Husqvarna Motorcycles authorized dealers nationwide from October 2015 through March 2016 for about $8,400.

     

    Importer(s)

    KTM North America, Inc., of Amherst, Ohio

     

    Distributor(s)

    KTM North America, Inc., of Amherst, Ohio

     

    Manufactured in

    Austria

     

     

     

    :wormie2:

    John

  22. http://www.cpsc.gov/en/Recalls/2016/SAHN-Designs-Recalls-Bicycle-Helmets/

     

     

    SAHN Designs Recalls Bicycle Helmets Due to Risk of Head Injury

     

    Recall date: SEPTEMBER 01, 2016

    Recall number: 16-256

     

    Recall Summary

    Name of product: SAHN Classic bicycle helmets

     

    Hazard: The helmets do not comply with the impact requirements of the federal safety standard for bicycle helmets, posing a risk of head injury.

     

    Consumer Contact:

    SAHN Designs at 800-642-7086 from 9 a.m. to 6 p.m. PT Monday through Friday or online at www.sahn.cc and click on “Recall Notice” at the top of the page for more information.

     

    Recall Details

    In conjunction with

     

     

     

     

    Canada Flag

     

    Units

    About 2,000 (in addition, about 1,600 were sold in Canada)

     

    Description

    This recall involves SAHN Classic SH523 adult bicycle helmets. “SAHN” is printed on the outer shell of the helmet on the right side. The production date and “SH-523 Classic” are printed on the white sticker label on the inside of the helmet. The helmets come in matte and gloss colors. Matte colors include black, white, blue, tan, grey, green, cream and brown. Gloss colors include black, white, blue, tan, cream and green.

     

    Incidents/Injuries

    None reported

     

    Remedy

    Consumers should immediately stop using the recalled bicycle helmets and contact SAHN Designs for a free replacement helmet.

     

    Sold at

    Authorized boutique bicycle dealers from May 2013 through December 2015 for about $130.

     

    Distributor(s)

    SAHN Designs Inc., of Vancouver, Canada

     

    Manufactured in

    China

     

     

     

    :wormie2:

    John

  23. http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-076-2016-release

     

     

    News Release

     

    Atherstone Foods Recalls Poultry Products Due to Misbranding and Undeclared Allergens

     

    Class II Recall

    076-2016

    Health Risk: Low

    Sep 1, 2016

     

    Congressional and Public Affairs

    Allie Ryan (202) 720-9113

    Press@fsis.usda.gov

    (202) 720-9113

     

    WASHINGTON, Sept. 1, 2016 – Atherstone Foods, a Richmond, Calif. establishment, is recalling approximately 422 pounds of chicken wrap products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains soy, a known allergen, which is not declared on the product label.

     

    The southwestern style white chicken wrap items were produced on August 29, 2016. The following products are subject to recall:

    View Labels PDF only

    http://www.fsis.usda.gov/wps/wcm/connect/24c26852-79e3-40dc-a5a8-08024ea366cc/076-2016-labels.pdf?MOD=AJPERES

     

    31.2 oz. packages containing 3 packages of 10.4 oz. “Greens & Grains Southwestern Style White Chicken Wrap with chimichurri sauce” with “Use By” date of 090616.

     

    The products subject to recall bear establishment number “P-34221” inside the USDA mark of inspection. These items were shipped to retail locations in California.

     

    The problem was discovered by the firm during routine label verification.

     

    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.

     

    Consumers and media with questions about the recall can contact Tom Atherstone, President/Owner, at (510) 236-3500.

     

     

     

    :wormie2:

    John

  24. http://www.fda.gov/Safety/Recalls/ucm518943.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    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.

     

    Summit Import Corporation Recalls Yu Yee Brand Black Pepper Powder Because of Possible Health Risk

     

    For Immediate Release

    August 31, 2016

     

    Contact

    Consumers

    Summit Import Corp.

    1-800-888-8228, Ext. 132

     

    Announcement

    View Product Photos

    http://www.fda.gov/Safety/Recalls/ucm518943.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-photos

     

    Summit Import Corp., at 100 Summit Place, Jersey City, New Jersey, is recalling Yu Yee brand Black Pepper Powder packed in clear plastic 19.4oz bottles under lot No. WH76 because it was found contain Salmonella an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e. infected aneurysms), endocarditis and arthritis.

     

    The recalled product Yu Yee brand Black Pepper Powder 19.4 oz bottle was distributed to some Asian retail stores in East Coast States.

     

    No illnesses have been reported to date in connection with this problem.

     

    The recall was initiated after samples collected and tested by VDAC (Virginia Dept. of Agriculture and Consumer Services) found the product contaminated with Salmonella.

     

    Consumers are urged to return this recalled product to the place of purchase. Consumers with questions may contact the company at 1-800-888-8228, Ext. 132, EST M-F from 10:00AM – 5:30PM Attention: Tony Lee.

     

     

     

    :wormie2:

    John

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