WormGuy
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News Release
Bunge's Meats Recalls Pork Products Formulated With Water That Did Not EPA Meet Drinking Water Standards
Class I Recall
082-2016
Health Risk: High
Sep 16, 2016
Congressional and Public Affairs
Gabrielle N. Johnston
(202) 720-9113
WASHINGTON, Sept.16, 2016 – Bunge’s Meats, a Catawissa, Penn. establishment, is recalling an undetermined amount of pork sausage products that were produced with water that did not meet the Environmental Protection Agency’s (EPA) drinking water standards, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The various pork sausage items were produced between Feb. 24, 2016 and Sept. 15, 2016.
The products subject to recall bear establishment number “EST. 21603” inside the USDA mark of inspection. These items were shipped to restaurants in Pennsylvania.
The problem was discovered on September 15, 2016, while an Enforcement, Investigations, and Analysis Officer (EIAO) was reviewing records during a Food Safety Assessment (FSA). The EIAO observed that results from the establishment’s third party testing laboratory indicated that water samples collected at the establishment on Feb. 24 and Sept. 9, 2016 were positive for Coliform bacteria. The water is used in the formulation of the pork sausage products.
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 and media with questions about the recall can contact Robert Bunge, Owner, at (570) 317-6702.
John
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News Release
Tucson Tamale Wholesale Company, LLC Recalls Beef Tamale Products Containing Meat Produced Without Benefit of Federal Inspection
Class I Recall
081-2016
Health Risk: High
Sep 16, 2016
Congressional and Public Affairs
Sarah R. Lichtman
(202) 720-9113
WASHINGTON, Sept. 16, 2016 – Tucson Tamale Wholesale Company, LLC, a Tucson, Ariz. establishment, is recalling approximately 915 pounds of beef tamale products that contain meat produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The ready-to-eat beef tamale items were produced on various dates from Aug. 11, 2016 to Sept. 13, 2016. The following products are subject to recall:
View Labels PDF Only
Bulk boxes containing 10- or 11-oz packages of two “Tucson Tamale Red Chile Beef Tamales,” with packaging dates of 8/11/2016, 8/15/2016, 8/22/2016, 8/31/2016 and 9/13/2016, and with case and package codes 2016224, 2016228, 2016235, 2016244 and 2016257.
Bulk boxes containing 10- or 11-oz packages of two “Tucson Tamale Chipotle Beef Tamales,” with packaging dates of 8/16/2016, 9/1/2016 and 9/2/2016, and with case and package codes 2016229, 2016245 and 2016246.
Bulk boxes containing 10- or 11-oz packages of two “Tucson Tamale Chipotle Beef & Cheese Tamales,” with packaging dates of 8/16/2016, 8/25/2016, 8/29/2016 and 9/2/2016, and with case and package codes 2016229, 2016238, 2016242 and 2016246.
The products subject to recall bear establishment number “EST. M45860” inside the USDA mark of inspection. These items were distributed to the firm’s restaurants in Arizona. These items were sold to consumers either in restaurants (without packaging), in foil “to-go” containers or with the original packaging intact.
The problem was discovered by FSIS personnel during routine inspection activities.
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 and members of the media with questions about the recall can contact Todd Martin, Owner, Tucson Tamale Wholesale Company, LLC, at (520) 398-6282.
John
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Public Notification: Stiff Bull Herbal Coffee contains hidden drug ingredient
9-16-2016
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Stiff Bull Herbal Coffee, a product promoted for improving energy. This product was identified by FDA during an examination of international mail shipments.
FDA laboratory analysis confirmed that Stiff Bull Herbal Coffee contains desmethyl carbodenafil. Desmethyl carbodenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online at MedWatch Online Voluntary Reporting Form,
https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
or; Download and complete the form, http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf
then submit it via fax at 1-800-FDA-0178.
Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.
Please refer to the links below for more information:
Tainted Sexual Enhancement Products
Beware of Fraudulent ‘Dietary Supplements’
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm246744.htm
John
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http://www.fda.gov/Food/RecallsOutbreaksEmergencies/SafetyAlertsAdvisories/ucm520985.htm
FDA Suspends Food Facility Registration of SM Fish Corp.
No food from the facility may be sold or distributed, Ossie’s and Ossie’s Gourmet ready-to-eat seafood products recalled
September 2016
Fast Facts
FDA is using authorities granted under the 2011 FDA Food Safety Modernization Act to suspend the food facility registration of SM Fish Corp. of Far Rockaway, NY, because food, including ready-to-eat (RTE) food, from this facility may be contaminated with L. monocytogenes (Listeria).
Consumers with any un-expired RTE food products manufactured by SM Fish should not eat these products, which were sold at the company’s seven retail outlets located in New York and New Jersey, and instead throw these products away. This is an expansion from the July 29, 2016 recall to include all un-expired RTE foods from SM Fish.
Consumers should be aware that symptoms of listeriosis can appear from a few days up to a few weeks after consumption of contaminated food.
FDA’s decision to suspend the registration of SM Fish was prompted by a second 2016 inspection showing widespread and persistent Listeria contamination throughout its food facility.
No food from SM Fish’s facility may be sold or distributed while the food facility registration is suspended.
What is the problem and what is being done about it?
FDA issued a Suspension of Food Facility Registration Order to SM Fish Corp.
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/CFSANFOIAElectronicReadingRoom/UCM521045.pdf of Far Rockaway, NY, after the agency’s newly-established Strategic Coordinated Outbreak Response and Evaluation (SCORE) decision-making body of key senior leaders requested additional sampling of the SM Fish facility and results showed widespread and persistent Listeria contamination. SCORE was created in April 2016 to ensure the agency engages in an integrated approach to identifying timely and efficient measures in order to help mitigate public health risks. Today, this decision-making body evaluates the complexities and considers a wide range of options for use of compliance and enforcement authorities as early in the process as possible.
SCORE requested a re-inspection of the SM Fish facility after a June 14, 2016 to July 6, 2016 inspection resulted in 29 of 105 environmental samples testing positive for Listeria. Some of these samples were adjacent to food contact surfaces. As a result of the inspection, FDA recommended that SM Fish recall certain ready-to-eat food products, which the company did on July 29. The company also briefly ceased operations at FDA’s request to revise its cleaning and sanitation procedures. The agency had inspected the firm in 2015 and found Listeria in 15 out of the 105 locations swabbed throughout the facility. FDA investigators issued a 483 inspection report outlining safety concerns and discussed with SM Fish actions it should take to reduce the prevalence of Listeria in its facility.
FDA re-inspected and re-sampled the SM Fish facility from August 15, 2016 to September 9, 2016 and learned that the firm’s cleaning and sanitation procedures were unsuccessful in solving its environmental Listeria contamination. Testing results showed that Listeria was detected in 12 out of the 116 locations swabbed throughout the facility, including on a direct food contact surface. Other locations found to harbor the bacteria were non-food contact surfaces that are in sufficient proximity to the food and food contact surfaces to create an increased risk of contaminating the food, particularly considering inspection observations. Whole genome sequencing matched some of the Listeria findings genetically to samples collected during the June/July 2016 inspection, as well as to samples collected during the 2015 inspection, indicating that at least three strains of Listeria have been consistently present in this facility during a two-year period.
Following the re-inspection and additional Listeria findings, FDA used authority granted under the 2011 Food Safety Modernization Act to suspend the food facility registration of SM Fish on September 14, 2016. SM Fish may not sell or distribute any food from SM Fish’s facility while its registration is suspended. The agency also recommended that SM Fish expand its July 29 recall to include all RTE foods within expiry, and the company issued the recall on September 15, 2016.
FDA will vacate the Suspension of Food Facility Registration Order and reinstate SM Fish’s food facility registration only when the agency determines that food from its facility no longer has a reasonable probability of causing serious adverse health consequences or death to humans.
What are the symptoms of listeriosis?
Listeriosis is a rare but serious illness usually caused by eating food contaminated with the bacteria called Listeria monocytogenes. Anyone who has experienced fever and muscle aches, sometimes preceded by diarrhea or other gastrointestinal symptoms, or developed fever and chills while pregnant after having eaten any recalled SM Fish products should seek medical care. Consumers should understand that symptoms can appear from a few days up to a few weeks after consumption of the contaminated food.
Who is at risk?
Listeriosis can be fatal, especially in certain high-risk groups. These groups include the elderly, and people with weakened immune systems and certain chronic medical conditions (such as cancer). In pregnant women, listeriosis can cause miscarriage, stillbirth, premature labor, and serious illness or death in newborn babies.
Consumer Advice
FDA advises consumers with any ready-to-eat fish products manufactured by SM Fish at this facility to not eat these products and instead throw them away. These products were sold at the firm’s retail outlets located in New York and New Jersey. This is an expansion from the July 29, 2016 recall.
Consumers who handled recalled product should follow these simple steps:
Wash the inside walls and shelves of the refrigerator, cutting boards and countertops; then sanitize them with a solution of one tablespoon of chlorine bleach to one gallon of hot water; then dry with a clean cloth or paper towel.
Always wash hands with warm water and soap following the cleaning and sanitization process.
If you are unsure of your risk, ask your healthcare provider.
Additional recommendations for preventing listeriosis are available at the CDC Listeria website.
Resources
http://www.cdc.gov/listeria/prevention.html
FDA Form 483 (Inspectional Observations) for SM Fish Corp.
September 9, 2016
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm521047.pdf
John
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http://www.cpsc.gov/en/Recalls/2016/Samsung-Recalls-Galaxy-Note7-Smartphones/
Samsung Recalls Galaxy Note7 Smartphones Due to Serious Fire and Burn Hazards
Recall date: SEPTEMBER 15, 2016
Recall number: 16-266
Recall Summary
Name of product: Samsung Galaxy Note7 smartphones sold prior to September 15, 2016
Hazard: The lithium-ion battery in the Galaxy Note7 smartphones can overheat and catch fire, posing a serious burn hazard to consumers.
Consumer Contact:
Contact your wireless carrier or place of purchase, call Samsung toll-free at 844-365-6197 anytime, or go online at www.samsung.com.
Recall Details
In conjunction with
Canada Flag Mexico Flag
Units
About 1 million
Description
This recall involves the Samsung Galaxy Note7 smartphone sold before September 15, 2016. The recalled devices have a 5.7 inch screen and were sold in the following colors: black onyx, blue coral, gold platinum and silver titanium with a matching stylus. Samsung is printed on the top front of the phone and Galaxy Note7 is printed on the back of the phone.
To determine if your phone has been recalled, locate the IMEI number on the back of the phone or the packaging, and enter the IMEI number into the online registration site www.samsung.com or call Samsung toll-free at 844-365-6197.
Incidents/Injuries
Samsung has received 92 reports of the batteries overheating in the U.S., including 26 reports of burns and 55 reports of property damage, including fires in cars and a garage.
Remedy
Consumers should immediately stop using and power down the recalled Galaxy Note7 devices purchased before September 15, 2016. Contact the wireless carrier, retail outlet or Samsung.com where you purchased your device to receive free of charge a new Galaxy Note7 with a different battery, a refund or a new replacement device. Go to www.samsung.com for more details.
Carrier/Retailer
Phone
Web
AT&T
1-800-331-0500
Best Buy
1-888-237-7289
http://www.bestbuy.com/site/clp/galaxy-note7-information/pcmcat748302046994.c?id=pcmcat748302046994
Sprint
1-888-211-4727
http://newsroom.sprint.com/news-releases/
T-Mobile
1-844-275-9309
U.S. Cellular
1-888-944-9400
http://www.uscellular.com/about/
Verizon
1-800-922-0204
http://www.verizonwireless.com/smartphones/
Sold at
Wireless carriers and electronic stores nationwide, including AT&T, Best Buy, Sprint, T-Mobile, US Cellular, Verizon stores and online at www.samsung.com and other websites from August 2016 through September 2016 for between $850 and $890.
Manufacturer(s)
Samsung Electronics America Inc., of Ridgefield Park, N.J.
Manufactured in
South Korea and China
John
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http://www.cpsc.gov/en/Recalls/2016/GE-Appliances-Recalls-Top-Loading-Clothes-Washers/
GE Appliances Recalls Top-Loading Clothes Washers Due to Fire Hazard
Recall date: SEPTEMBER 15, 2016
Recall number: 16-265
Recall Summary
Name of product: GE Profile™ top-loading clothes washers
Hazard: An electrical component in the washers can overheat, posing a fire hazard.
Consumer Contact:
GE Appliances toll-free at 877-830-9732 between 8 a.m. and 5 p.m. ET Monday through Friday or online at www.geappliances.com and click “Recall Information” at the bottom of the page for more information.
Recall Details
In conjunction with
Canada Flag
Units
About 222,000 (in addition, about 450 were sold in Canada)
Description
The recall involves three models of GE Profile high-efficiency top-loading clothes washers. The washers come in gold, gray and white and measure about four cubic feet. “GE Profile” is printed on the front of the washers. The model number is located on the rear cover of the washer’s backsplash, above the water valve connections. Recalled washers have the following model and serial number ranges:
Brand
Model
Serial Number
GE Profile
WPGT9350
WPGT9360
WPGT9150
All serial numbers included
Incidents/Injuries
GE Appliances has received 71 reports of internal washer components burning or catching fire, including three reports of fires resulting in about $129,000 in property damage. No injuries have been reported.
Remedy
Consumers should immediately unplug and stop using the recalled washers and contact GE Appliances for a free repair.
Sold at
Best Buy, Lowe’s, Sears, The Home Depot and other stores nationwide from June 2003 through October 2011 for between $900 and $1,400.
Manufacturer(s)
GE Appliances, of Louisville, Ky.
Importer(s)
GEA Products, L.P., of Louisville, Ky.
Manufactured in
South Korea
John
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http://www.cpsc.gov/en/Recalls/2016/Polaris-Recalls-Ranger-Recreational-Off-Highway-Vehicles/
Polaris Recalls Ranger Recreational Off-Highway Vehicles Due to Fire and Burn Hazards
Recall date: SEPTEMBER 15, 2016
Recall number: 16-264
Recall Summary
Name of product: Polaris Ranger 900 recreational off-highway vehicles (ROVs)
Hazard: The heat shield can fall off the vehicle, posing fire and burn hazards to riders.
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” at the bottom of the page for more information.
Recall Details
Units
About 42,500
Description
This recall involves all model year 2014 Polaris Ranger XP 900, XP 900 EPS, and CREW 900 recreational off-highway vehicles (ROVs). The recalled ROVs were sold in a variety of colors and have either three or six seats and a rear box. “Ranger” is printed on the rear box, and “900” is printed on the hood of the ROVs. All 2014 Ranger 900 models and Vehicle Identification Numbers (VINs) are included in this recall. To check for recalled vehicles by VIN, visit www.polaris.com.
Incidents/Injuries
Polaris has received 36 reports of the recalled ROVs overheating and catching on fire, including reports of three minor burns and one sprained wrist.
Remedy
Consumers should immediately stop using the recalled ROVs and contact Polaris to schedule a free repair. Polaris is contacting all known purchasers directly.
Sold at
Polaris dealers nationwide from April 2013 through June 2014 for between $13,200 and $16,200.
Importer(s)
Polaris Industries Inc., of Medina, Minn.
Distributor(s)
Polaris Industries Inc., of Medina, Minn.
Manufactured in
U.S. and Mexico
John
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Bungee Chairs Sold Exclusively at Big 5 Sporting Goods Stores Recalled Due to Fall Hazard; Made by Nanjing Kekang Outdoor Products
Recall date: SEPTEMBER 15, 2016
Recall number: 16-263
Recall Summary
Name of product: Bungee chairs
Hazard: The chair rivets can break while in use, posing a fall hazard to the consumer.
Consumer Contact:
Nanjing Kekang Outdoor Products toll-free at 866-283-4412 from 8 a.m. to 4 p.m. ET Monday through Friday, or online at www.big5sportinggoods.com and click on “Product Recall” at the bottom of the homepage for more information.
Recall Details
Units
About 4,100
Description
This recall involves Captiva Designs bungee chairs with model number AC098 printed on the header cards of the product packages. The collapsible chair has a navy blue and teal nylon and bungee seat and black metal legs. The chair’s bungee cords are laced through the seat frame.
Incidents/Injuries
The firm has received three reports of chair rivets breaking, including two reports of injuries from falls.
Remedy
Consumers should immediately stop using the recalled bungee chairs and return them to any Big 5 Sporting Goods store for a full refund.
Sold exclusively at
Big 5 Sporting Goods stores nationwide from May 2016 through July 2016 for about $30.
Importer(s)
Big 5 Sporting Goods, of El Segundo, Calif.
Distributor(s)
Big 5 Sporting Goods, of El Segundo, Calif.
Manufactured in
China
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.
SM Fish Corp Recalls Select Ossie’s Ready to Eat Salads Because of Possible Health Risk
For Immediate Release
September 15, 2016
Contact
Consumers
SM Fish Corp
(718) 945-9838
Announcement
SM Fish Corp. of Far Rockaway, NY, is voluntarily recalling OSSIE’S brand ready-to-eat salads because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
The recalled products were sold at the firm’s seven retail outlets located in New York and New Jersey between August 1, 2016 and September 9, 2016.
The recalled products were packed in plastic deli containers with a UPC Code and “Best By” date codes of 8/21/16 through 10/18/16 (located on the bottom of the tub):
OSSIE’S PICKLED LOX DAIRY, NET WT. 8 OZ., UPC 739885114136
OSSIE’S HERRING IN SOURCREAM, NET WT. 8 OZ., UPC 739885114174
OSSIE’S TAAM SHABBOS HERRING, NET WT. 7 OZ., UPC 739885109057
OSSIE’S STIGLITZ HERRING, NET WT. 7 OZ., UPC 739885109064
OSSIE’S WASABI HERRING, NET WT. 7 OZ., UPC 739885109088
OSSIE’S SWEDISH MATJES HERRING, NET WT. 7 OZ., UPC 739885109101
OSSIE’S DUBLIN HERRING, NET WT. 7 OZ., UPC 739885109002
OSSIE’S HONEY MUSTARD HERRING; NET WT. 7 OZ. 739885109019
OSSIE’S PICKLED LOX & CREAM, NET WT. 8 OZ., UPC 739885104113
OSSIE’S SHMALTZ HERRING, NET WT. 8 OZ., UPC 739885104182
OSSIE’S ROMAN SHMALTZ HERRING, NET WT. 7 OZ., UPC 739885109026
OSSIE’S PICKLED HERRING, NET WT. 8 OZ., UPC 739885104175
OSSIE’S PICKLED HERRING CLEAR, NET WT. 8 OZ., UPC 739885104205
OSSIE’S PICKLED LOX, NET WT. 8 OZ., UPC 739885104137
OSSIE’S EGG SALAD, NET WT. 7OZ., UPC 73988570552
OSSIE’S EGG WITH MUSHROOM, NET WT. 7OZ., UPC 73988570556
OSSIE’S EGG WITH SCALLION, NET WT. 7OZ., UPC 73988570555
OSSIE’S LITE TUNA, NET WT. 7OZ., UPC 73988570551
OSSIE’S HOME MADE TUNA SALAD, NET WT. 7OZ., UPC 73988570550
No illnesses have been reported to date.
The recall was the result of sampling and inspectional findings by the US Food and Drug Administration (FDA). FDA found Listeria monocytogenes in multiple locations throughout the facility. SM Fish Corp. has ceased production and distribution of products following discussion with FDA on September 8, 2016. The company and the FDA continue their investigation as to the cause of the problem.
Consumers who have purchased any of the above listed products are urged not to consume them and promptly discard. Consumers with questions may contact the company at (718) 945-9838, Monday - Friday, 9 am - 4 pm EDT, or via email at: recallssmf@gmail.com.
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.
Virtus Pharmaceuticals Opco II, LLC Issues Voluntary Nationwide Recall of Hyoscyamine sulfate Due to Superpotent and Subpotent Results
For Immediate Release
September 14, 2016
Contact
Consumers
1-855-255-6076
Media
William Jones
(202) 930-1395
Announcement
View Product Photos
Virtus Pharmaceuticals Opco II, LLC (Virtus) is voluntarily recalling seven batches of Hyoscyamine sulfate (0.125mg) listed in the table below, to the consumer level which include the tablet, sublingual, and orally disintegrating tablet form. This recall is being initiated due to both superpotent and subpotent test results. All of these batches were manufactured by Pharmatech LLC for distribution by Virtus throughout the United States and Puerto Rico.
Hyoscyamine Sulfate 0.125 mg Recalled Batches
Form
NDC
Package Size
Batch #
Expiry
Sublingual Tablets
76439-309-10
100-count
30051601
Jan-18
30051602
Jan-18
Jan-28*
30051603
Jan-18
30051604
Jan-18
Oral Disintegrating
Tablets 76439-307-10
100-count
30011601
Jan-18
Tablets
76439-308-10
100-count
30031601
Jan-18
30031602
Jan-18
*A small number of bottles from this lot have the incorrect expiration date printed on them.
Taking a product that is superpotent could result in hot/dry skin, fever, blurred vision, sensitivity to light, dry mouth, unusual excitement, fast or irregular heartbeat, dizziness, an inability to completely empty the bladder, and seizures. The severity of the adverse event would depend on how superpotent the tablet was. Adverse events such as clotted blood within the tissues and fractures could occur, as a result of falls from dizziness or seizures if the strength is particularly high. To date, Virtus has received three adverse event reports involving hallucinations, stroke-like symptoms, confusion, dizziness, blurred vision, dry mouth, slurred speech, imbalance, and disorientation. These symptoms were reported to be resolved are all believed to be temporary. None of the adverse events were life threatening, and the patients who reported the incidents were treated and released.
Hyoscyamine sulfate is an anticholinergic agent which blocks the action of acetylcholine and is used to treat diseases like asthma, incontinence, stomach cramps, peptic ulcers, control gastric secretion, intestinal spasm and other bowel disturbances. These products were distributed Nationwide in the U.S. and Puerto Rico starting on March 11, 2016, to distributors, hospitals, and retail pharmacies.
Virtus is notifying its distributors and retailers by letter and email and is arranging for return of all recalled drug product. Consumers, distributors, and retailers that have the hyoscyamine sulfate product lots listed above should stop using/distributing and return to place of purchase.
Consumers with questions regarding this recall can contact Virtus at 1-855-255-6076 on Monday through Friday from 8 am to 5 pm EST or rxrecalls@inmar.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.
Adverse reactions or quality problems experienced with the use of this product 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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
About Virtus
Virtus Pharmaceuticals is a specialty niche pharmaceutical company focused on the development and marketing of prescription products to pharmaceutical wholesalers, distributors and retailers across the United States. Virtus offers its customers a diversified product portfolio covering a broad range of therapeutic areas, including prenatal vitamins, women’s health, vitamin supplements, anti- bacterials, and others, in a variety of dosage forms. Virtus is headquartered in Tampa, FL.
John
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http://www.cpsc.gov/en/Recalls/2016/Huish-Outdoors-Recalls-Buoyancy-Control-Devices-BCDs/
Huish Outdoors Recalls Buoyancy Control Devices (BCDs) Due to Drowning Hazard
Recall date: SEPTEMBER 14, 2016
Recall number: 16-262
Recall Summary
Name of product: Zeagle brand buoyancy control devices (BCDs)
Hazard: The buoyancy control devices can suddenly leak air causing a loss of flotation, posing a drowning hazard to scuba divers.
Consumer Contact:
Huish Outdoors toll-free at 888-270- 8595 between 8 a.m. and 5 p.m. PT Monday through Friday or online at www.zeagle.com and click on recall notice for more information .Consumers can also e-mail the firm at recall@huishoutdoors.com.
Recall Details
In conjunction with
Canada Flag
Units
About 1,400 (in addition, about 50 were sold in Canada)
Description
This recall involves all Zeagle brand Grace and Element BCDs. BCDs are used to help a diver maintain buoyancy under water during scuba diving. The Grace model is black with light green accents and has the logo “Z/Grace” on the right side pocket and left shoulder. The words “Zeagle Sport” are on the left side pocket. The Element model is black with red accents and has the logo “Z/Element” on the right side pocket and left shoulder. The words “Zeagle Sport” are on the left side pocket.
Incidents/Injuries
The firm has received one report of a seam failure in the BCD resulting in air leakage. No injuries have been reported.
Remedy
Consumers should immediately stop using the recalled BCDs and return them to Huish Outdoors or an authorized Zeagle dealer for a free replacement.
Sold at
Authorized Zeagle dealers and online at www.zeagle.com for about $412 for the Grace model and about $490 for the Element model BCD, from September 2015 through August 2016.
Manufacturer(s)
Huish Outdoors LLC, Salt Lake City, Utah
Manufactured in
Vietnam
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.
Drew’s, LLC Issues Allergy Alert on Undeclared Milk and Egg in One Lot of Field Day Organic Ranch Dressing
For Immediate Release
September 14, 2016
Contact
Consumers
Drew’s, LLC
1-800-228-2980
Announcement
View Product Photos
Drew’s, LLC of Chester, VT is voluntarily recalling one lot code of Field Day Organic Ranch Dressing due to product mislabeling that has resulted in an undeclared milk and egg allergen. Consumers who have severe allergies to milk and/or egg run the risk of serious or life- threatening allergic reaction if they consume this product.
The recalled product comes in an 8 fl. oz. glass bottle with the lot code W210I, Best By date of Jan. 28, 2018, and UPC #042563600242. The lot code is located on the back of the bottle above the label. Specifically, the front label of the affected product is correctly labeled Field Day Organic Ranch Dressing, 8 fl oz. The issue is some bottles have an incorrect back label such that the contains statement does not list milk and egg as allergens. These bottles can be identified by UPC# 042563600259.
This action is being taken in cooperation with the US FDA. Product has been distributed in retail stores nationwide.
To date, no illnesses related to this product have been reported. No other Field Day products are affected by this recall.
The recall was initiated after Field Day notified Drew’s LLC that the incorrect back label was used on lot W210I and had entered trade.
Consumers can return the product to their place of purchase for a full refund.
For more information, please contact Drew’s, LLC between 8:30AM-4:30PM EST Monday- Friday at 1-800-228-2980 or email info@chefdrew.com.
John
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News Release
WFSP Foods, LLC Recalls Pork and Chicken Sausage Products Due To Misbranding and Undeclared Allergens
Class I Recall
075-2016
Health Risk: High
Aug 26, 2016
Distribution List PDF
Congressional and Public Affairs
Maria Machuca
(202) 720-9113
WASHINGTON, Aug. 26, 2016 – WFSP Foods LLC, a Decatur, Ala. establishment, is recalling approximately 18,672 pounds of pork and chicken sausage products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products contain milk, a known allergen which is not declared on the product label.
The ready-to-eat sausage items were produced on June 7, 2016. The following product is subject to recall:
View Labels PDF Only
13.5-oz. packages containing “Land O’ Frost Simply Savory Bacon & Cheddar Smoked Sausage” with a “BEST BY: DEC. 04 2016” and packaging date of 06/07/16.
The product subject to recall bears establishment number “EST. 45411” printed on the packaging. This item was shipped to retail locations nationwide.
The problem was discovered in a retail store by a company representative and immediately reported to FSIS. The product has the correct label on the front of the package, which identifies that the product contains cheese. However, the label in the back fails to include cheddar cheese as an ingredient – the source of milk. As a result, milk is not included in the ingredients statement or in the “Contains” allergen declaration.
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 will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Consumers with questions about the recall can contact the Land O’ Frost Consumer Hotline, at 1(800) 762-9865. Media with questions about the recall can contact Jack Yeo with Fleishman Hillard, at (312) 560-1465.
Consumers with questions about the recall can contact the Land O’ Frost Consumer Hotline, at 1(800) 762-9865. Media with questions about the recall can contact Jack Yeo with Fleishman Hillard, at (312) 560-1465.
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.
New Seasons Market Issues Allergy Alert on Undeclared Peanuts in Creamy Almond Butter
For Immediate Release
September 13, 2016
Contact
Consumers
New Seasons Market
Media
Sara Stewart
(503) 231-3086
Announcement
View Product Photos
PORTLAND, Ore. – New Seasons Market has initiated a voluntary recall of its New Seasons Market 16oz. Creamy Almond Butter because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of a serious or life-threatening allergic reaction if they consume this product.
The recall affects customers who purchased the product with best by dates of 06/16/2017, 08/15/2017 and 08/30/2017 at New Seasons’ 19 locations in Oregon, Southern Washington and Northern California.
The voluntary recall is limited to the production codes of the one product listed below. Customers can find the UPC Code beneath the bar code on the product label and the Best-By-Date above the label on the clear plastic jar. No other production codes, sizes or varieties of New Seasons Market nut butters are affected by this recall. The mislabeled jars were discovered by New Seasons staff during a routine stock rotation check.
Product Name
UPC Code
Best By Dates
New Seasons Market Creamy Almond Butter
4060010401
06/16/2017
08/15/2017
08/30/2017
There have been no reports of illness to date, but to ensure customer safety, New Seasons is urging customers with any peanut health concerns or allergies to return the recalled New Seasons Market Creamy Almond Butter for a full refund. Receipts are not required for the return. New Seasons is standing by to answer customer questions at its stores or via email: talktous@newseasonsmarket.com.
Committed to reducing food waste and fighting hunger, New Seasons will evaluate the returned and unopened products for their safety and compliance. Those mislabeled will be destroyed. New Seasons Market will coordinate with hunger relief partners to get only the safe products into the hands of people in need.
About New Seasons Market
New Seasons Market is a West Coast neighborhood grocer with a people-first culture that builds and sustains relationships for the greater good. A champion of the regional food economy, it partners with farmers, ranchers and producers to deliver the best of the region and pairs local, organic favorites with grocery classics to offer customers choice, value and flexibility. The world’s first certified B Corp grocery store using the power of business for good, New Seasons Market started with a single store in Portland, Ore., in 2000 when three families and 50 friends united over shared values. Together with its 3,300 plus welcoming staff members, New Seasons Market offers a unique retail experience in which communities come together to realize the potential of a healthy, sustainable food system. New Seasons Market has 19 neighborhood stores in Washington, Oregon and California, as well as five New Leaf Community Market locations in Northern California, and commits 10% of its after-tax profits back to the communities it serves.
John
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http://www.cpsc.gov/en/Recalls/2016/BLACK-DECKER-Recalls-Electric-Blower-Vacuum-Mulchers/
BLACK+DECKER™ Recalls Electric Blower/Vacuum/Mulchers Due to Laceration Hazard
Recall date: SEPTEMBER 13, 2016
Recall number: 16-261
Recall Summary
Name of product: BLACK+DECKER electric blower/vacuum/mulchers
Hazard: The fan cover can unlatch unexpectedly, posing a laceration hazard.
Consumer Contact:
BLACK+DECKER toll-free at 866-937-9805 from 8 a.m. to 5 p.m. ET Monday through Friday or online at www.blackanddecker.com and click on Safety Recalls for more information. Consumers can also email the firm at recall@sbdinc.com.
Recall Details
In conjunction with
Canada Flag
Units
About 560,000 (in addition, about 20,000 were sold in Canada)
Description
This recall involves BLACK+DECKER 3-in-1 electric blower/vacuum/mulchers with model numbers BV5600, BV6000 and BV6600. The model number and “Type 1” are printed on the name plate on the right side of the motor housing. Only “Type 1” blower/vacuum/mulchers are included in this recall. They are orange with black accents, a black fan cover and a two-speed switch. They were sold with a blower tube, a vacuum tube and a reusable collection bag. Model BV6600 also has a rake attachment.
Incidents/Injuries
BLACK+DECKER has received four reports of the fan covers unexpectedly coming off and consumers receiving finger lacerations from contact with the fan.
Remedy
Consumers should immediately stop using the recalled product and contact BLACK+DECKER for a free repair kit, which includes a replacement fan cover.
Sold at
Lowes and other stores nationwide and online at Amazon.com and other websites from May 2013 through September 2016 for between $70 and $90.
Importer(s)
BLACK+DECKER (U.S.) Inc., of Towson, Md.
Distributor(s)
BLACK+DECKER (U.S.) Inc., of Towson, Md.
Manufactured in
China
John
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News Release
PT Farm, LLC Recalls Lamb Products Due To Possible E. Coli Contamination
Class I Recall
078-2016
Health Risk: High
Sep 9, 2016
Distribution List PDF
Congressional and Public Affairs
Veronika Medina
(202) 720-9113
WASHINGTON, Sept. 9, 2016 – PT Farm, LLC, a North Haverhill, N.H. establishment, is recalling approximately 15 pounds of lamb products that may be contaminated with E. coli, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The lamb products, a neck and one leg, were derived from a carcass produced on Sept. 6, 2016 and were shipped to a retail store in Somerville, Massachusetts and sold at their retail counter on Sept. 7, 2016.
The problem was discovered on Sept. 7, 2016 when the establishment was notified of an E. coli positive water supply sample result and resulting "water boil" notice initiated by the North Haverhill Municipality Water Department located in North Haverhill, New Hampshire.
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.
Media and consumers with questions regarding the recall can contact Peter L. Roy, company owner, at (603) 787-9199.
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.
Shearer’s Foods, LLC Issues Allergy Alert On Undeclared Soy And Milk In No Salt Added Kettle Cooked Potato Chips
For Immediate Release
September 9, 2016
Contact
Consumers
Shearer’s Consumer Affairs Department
1-800-428-6843
Announcement
Shearer’s Foods, LLC of Massillon, OH is recalling Meijer brand 8.5 ounce packages of No Salt Added Kettle Cooked Potato Chips because they may contain undeclared soy and milk. People who have allergies to soy and/or milk run the risk of serious or life-threatening allergic reaction if they consume these products.
The recalled No Salt Added Kettle Cooked Potato Chips were distributed to Meijer stores throughout the Midwest from August 10, 2016 until September 8, 2016.
The product comes in an 8.5 ounce bag marked the UPC # 719283595577 and with an expiration date on the package of OCT 31 2016. A total of 280 cases were affected. All 280 cases of the recalled No Salt Added Kettle Cooked Potato Chips were distributed to Meijer stores.
No illnesses have been reported to date in connection with this problem.
The recall was initiated after a consumer discovered that there were Salt & Pepper Potato Chips (which contain soy and milk) in a package labeled as No Salt Added Potato Chips, which did not reveal the presence of these allergens. Subsequent investigation revealed we inadvertently added a small quantity of the Salt and Pepper potato chips into the No Salt Added packages.
Customers who purchased the recalled product from Meijer’s may dispose of it or return the product to its place of purchase for a full refund. Consumers with questions may contact Shearer’s Consumer Affairs Department toll free at 1-800-428-6843 Monday through Friday, between 9:00 a.m. and 4:00 p.m. Eastern time.
John
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News Release
Savory Foods Recalls Pork Rinds Due To Misbranding and Undeclared Allergen
Class II Recall
080-2016
Health Risk: Low
Sep 10, 2016
Congressional and Public Affairs
Nina Anand
(202) 720-9113
WASHINGTON, Sept. 10, 2016 – Savory Foods, a Portsmouth, OH establishment, is recalling approximately 32,928 pounds of pork rind products due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains wheat, a known allergen which is not declared on the product label.
The Hot and Spicy Pork Rind items were produced from August 11, 2015 to August 31, 2016. The following products are subject to recall:
View Labels PDF Only
3.5-oz. PLASTIC BAGS containing pieces of “UTZ HOT AND SPICY PORK RINDS CHICHARRONES” with use by codes of 2475 NOV 28/15 to 2475 DEC 9/16:
The products subject to recall bear establishment number “EST. 1001” printed by the USE BY DATE in the upper right hand side of the bag. These items were shipped to a distribution center in Pennsylvania.
The problem was discovered by FSIS personnel during a routine label review.
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 with questions about the recall can contact Arturo C. Gutierrez de Velasco, VP of Operations, (773)-402-8267. Media with questions about the recall can contact Craig Leese, CFO, (773)-321-6936.
John
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News Release
MIH Marketing and Sales Recalls Meat and Poultry Products Due To Insanitary Conditions
Class I Recall
079-2016
Health Risk: High
Sep 10, 2016
Congressional and Public Affairs
Nina Anand
(202) 720-9113
WASHINGTON, Sept. 10, 2016 – MIH Marketing and Sales, a Beebe, AR. establishment, is recalling approximately 662,049 pounds of various meat and poultry products that were stored under insanitary conditions, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The raw chicken breast fillet, chicken thigh, chicken drum, chicken wing, and chicken tender items were produced by various federal establishments and sold at 17 retail stores located in Arkansas between April 10, 2016 and September 10, 2016. These products were in clear packages weighting approximately 5 pounds each.
Products were sold at the following locations:
Edwards Food Giant #19 Forrest City, AR;
Edwards Cash Saver #3473 Little Rock, AR;
Edwards Food Giant #37 Marianna, AR;
Edwards Good Giant #3474 Little Rock, AR;
Edwards Food Giant #1710 Harrisburg, AR;
Edwards Food Giant #3475 Little Rock, AR;
Edwards Food Giant #3444 Bryant, AR;
Edwards Cash Saver #3476; Edwards Cash Saver #3442 and Edwards Food Giant #3477;
Knight’s Super Foods, Beebe AR;
Knight’s Super Foods, Babot, AR.
In addition, various retail meat and poultry products sold at Chicken City Retail stores are being recalled. These products are in clear retail bags with a sales sticker that include the Sell-By Date between October 30, 2016 and March 19, 2017. The Chicken City Retail Stores that are recalling all meat and poultry products are located in Whitehall, AR; Jonesboro, AR; Conway, AR; Searcy, AR Marion, AR; North Little Rock, AR and Brinkley, AR.
The problem was discovered while the FSIS Office of Investigation, Enforcement and Audits (OIEA) was conducting routine food defense surveillance activities. The FSIS OIEA investigator discovered that the product was being stored under insanitary conditions, including rodent activity, in the storage areas of the property. FSIS and the establishment detained the remaining product. The items subsequently tested positive for alkaline phosphatase, demonstrating evidence of possible fecal matter.
There have been no confirmed reports of adverse reactions due to consumption of these products. FSIS has received no additional reports of injury or illness from 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 and media with questions about the recall can contact John Hilger, Owner of MIH Marketing and Sales, at (501) -278-7041.
John
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News Release
Paradise Valley Market, Inc. (Carnival Supermarket) Recalls Ground Beef Products due To Possible E. Coli O157:H7 Adulteration
Class I Recall
077-2016
Health Risk: High
Sep 8, 2016
Distribution List PDF
Congressional and Public Affairs
Jeremy J. Emmert
(202) 720-9113
WASHINGTON, Sept. 8, 2016 – The Paradise Valley Market, Inc. (Carnival Supermarket), located at 870 3rd Avenue, Chula Vista, Calif., is voluntarily recalling approximately 35 pounds of ground beef products that may be adulterated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The lean and extra lean ground beef was produced and sold only on Sept. 1, 2016. The following products are subject to recall:
20-lbs. of 15% lean ground beef product. The product would have been packaged to order and sold at the Carnival Supermarket meat counter in reddish plastic bags with a tied knot at the top.
15-lbs. of 7% extra lean ground beef product. The product would have been packaged to order and sold at the Carnival Supermarket meat counter in reddish plastic bags with a tied knot at the top.
The problem was discovered when FSIS received notification that a product sample collected at the firm tested positive for E. coli O157:H7. There have been no confirmed reports of illness or 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 issued the voluntary recall over concerns 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 product 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 call Sandy Young, Vice President of J. Walcher Communications, at (619) 295-7140.
John
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News Release
PT Farm, LLC Recalls Lamb Products Due To Possible E. Coli Contamination
Class I Recall
078-2016
Health Risk: High
Sep 9, 2016
Congressional and Public Affairs
Veronika Medina
(202) 720-9113
WASHINGTON, Sept. 9, 2016 – PT Farm, LLC, a North Haverhill, N.H. establishment, is recalling approximately 15 pounds of lamb products that may be contaminated with E. coli, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The lamb products, a neck and one leg, were derived from a carcass produced on Sept. 6, 2016 and were shipped to a retail store in Somerville, Massachusetts and sold at their retail counter on Sept. 7, 2016.
The problem was discovered on Sept. 7, 2016 when the establishment was notified of an E. coli positive water supply sample result and resulting "water boil" notice initiated by the North Haverhill Municipality Water Department located in North Haverhill, New Hampshire.
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.
Media and consumers with questions regarding the recall can contact Peter L. Roy, company owner, at (603) 787-9199.
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.
Publix Recalls Apple Coffee Cakes (Foreign Matter-Metal)
For Immediate Release
September 8, 2016
Contact
Consumers
1-800-242-1227 or
1-888-SAFEFOOD (1-888-723-3366)
Announcement
LAKELAND, Fla. – Publix Super Markets is issuing a voluntary recall for Apple Coffee Cakes due to the possible presence of small metal shavings.
The Apple Coffee Cakes were sold at Publix bakery departments in Georgia, South Carolina, Alabama, Tennessee, North Carolina and the following counties in Florida: Alachua, Charlotte, Citrus, Collier, DeSoto, Hernando, Highlands, Hillsborough, Lee, Manatee, Marion, Pasco, Pinellas, Polk and Sarasota.
The product has a UPC of 002-19562-00000 and includes all date codes.
"As part of our commitment to food safety, potentially impacted product has been removed from store shelves,” said Maria Brous, Publix media and community relations director. "To date, there have been no reported cases of illness or injury. Consumers who have purchased the product in question may return the product to their local store for a full refund.
Publix customers with additional questions may call our Customer Care department at 1-800-242-1227 or contact us by visiting our website at www.publix.com. Customers can also contact the US Food and Drug Administration at 1-888-SAFEFOOD (1-888-723-3366).”
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.
Novo Nordisk Inc. issues voluntary nationwide recall of six batches of GlucaGen® HypoKit® (glucagon [rDNA origin] for injection) due to detached needles on the syringe in the kit
For Immediate Release
September 8, 2016
Contact
Consumers
Customer Service
1-888-840-1137
Media
Ken Inchausti
1-609-786-8316
Announcement
View Product Photos
Plainsboro, NJ - Novo Nordisk Inc. is recalling six batches of the GlucaGen® HypoKit® in the U.S. due to two customer complaints from the UK and Portugal involving detached needles on the syringe with Sterile Water for Injection (SWFI). GlucaGen® HypoKit® is indicated for the treatment of severe hypoglycemia (low blood sugar) in patients with diabetes who are treated with insulin. A syringe with a detached needle cannot be used as prescribed.
Untreated hypoglycemia can eventually lead to unconsciousness and seizures, which can prove fatal. If the blood glucose levels are not quickly restored, continuing hypoglycemia can lead to a decline in brain glucose levels which manifests through a variety of symptoms including cognitive dysfunction, sweating, tremors, convulsion and eventually coma or death.
Novo Nordisk conducted an investigation which showed that a small number (0.006%) of needles could be detached from the syringe in certain batches of GlucaGen® HypoKit®. To protect patient safety, Novo Nordisk is recalling affected batches from wholesalers, pharmacies and patients in the U.S. It is estimated that out of the 71,215 pens being recalled, four pens could be defective.
This recall includes GlucaGen® HypoKit® batch numbers:
· Batch: FS6X270, Expiry: 09/30/2017
· Batch: FS6X296, Expiry: 09/30/2017
· Batch: FS6X538, Expiry: 09/30/2017
· Batch: FS6X597, Expiry: 09/30/2017
· Batch: FS6X797, Expiry: 09/30/2017
· Batch: FS6X875, Expiry: 09/30/2017
The affected products were distributed starting February 15, 2016.
Novo Nordisk is working as quickly as possible and in collaboration with the U.S. Food and Drug Administration (FDA) to recall affected products from the marketplace, including those in the possession of patients. To date, Novo Nordisk is not aware of any known adverse events resulting from the use of the recalled batches.
Patients or caregivers should check the batch number to see if their GlucaGen® HypoKit® is affected. The batch number is printed on the GlucaGen® HypoKit® as indicated below in the red box (Figure 1).
Figure 1. A) GlucaGen® HypoKit® where the batch number is found in the red box,
close up of the batch number.If you have a GlucaGen® HypoKit® with one of the above-mentioned batch numbers, call 1-888-840-1137 from Monday to Friday, between 8:30am - 6:00pm Eastern Time, to find out how to return the product. Novo Nordisk will provide reimbursement for out-of-pocket costs incurred for the purchase for your affected GlucaGen® HypoKit® with proof of purchase. If you received a GlucaGen® HypoKit® through the Novo Nordisk Patient Assistance Program, you will receive a replacement device.
If you are in possession of a GlucaGen® HypoKit® with a batch number NOT mentioned above, the product is not subject to the recall and may be used as prescribed.
Novo Nordisk Inc. is notifying its distributors and customers by letter and phone and is arranging for return of all recalled products.
Adverse reactions or quality problems experienced with the use of this product may be reported to Novo Nordisk by calling 1-800-727-6500. Patients can also call 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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Novo Nordisk is committed to patient safety and delivering high-quality medicines, and is working to take corrective actions and avoid re-occurrence.
Indications and Usage
What is GlucaGen® (glucagon [rDNA origin] for injection) HypoKit®?
GlucaGen® HypoKit® is a prescription medicine used to treat very low blood sugar (severe hypoglycemia) in people with diabetes who use insulin.
Important Safety Information
Who should not use GlucaGen® HypoKit®?
Do not use GlucaGen® HypoKit® if:
· you are allergic to glucagon or lactose or any of the ingredients in GlucaGen®
HypoKit®
· you have a tumor in the gland on top of your kidneys (adrenal gland) called a pheochromocytoma
· you have a tumor in your pancreas called an insulinoma
What should I tell my doctor before using GlucaGen® HypoKit®?
Before using GlucaGen® HypoKit®, tell your doctor about all of your medical conditions, including if you:
· have kidney problems
· have pancreas problems. Tumors in your pancreas called glucagonomas
· have not had food or water for a long time (prolonged fasting or starvation)
· have low blood sugar that does not go away (chronic hypoglycemia)
· have heart problems
· are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed. It is not known if GlucaGen® HypoKit® passes into your breast milk
Tell your doctor about all the medicines you take, including prescription and over- the-counter medicines, vitamins and herbal supplements. GlucaGen® HypoKit® ® may affect the way other medicines work, and other medicines may affect how GlucaGen® HypoKit® works.
How should I use GlucaGen® HypoKit®?
· Read the detailed Instructions for Use that come with GlucaGen® HypoKit®.
· Use GlucaGen® HypoKit® exactly as your doctor tells you to.
· Make sure that you and your family know how to use GlucaGen® HypoKit® the right way before you need it.
· Act quickly. Having low blood sugar for a period of time may be harmful.
Call for emergency medical help right after you use GlucaGen® HypoKit®.
· Eat sugar or a sugar-sweetened product such as a regular soft drink or fruit juice as soon as you are able to swallow.
· Tell your doctor each time you use GlucaGen® HypoKit®. Your doctor may need to change the dose of your diabetes medicines.
What should I avoid while using GlucaGen® HypoKit®? While using GlucaGen® HypoKit® do not:
· drive or operate machinery until you have eaten sugar or a sugar-sweetened product such as a regular soft drink or fruit juice.
What are the possible side effects of GlucaGen® HypoKit®? GlucaGen® HypoKit® may cause serious side effects, including:
· High blood pressure. High blood pressure is common after taking GlucaGen® HypoKit® and can be severe.
· Low blood sugar. GlucaGen® HypoKit® can cause low blood sugar in patients
with tumors in their pancreas called insulinomas and glucagonomas by making too much insulin in their bodies.
· Allergic reactions. Symptoms of a serious allergic reaction to GlucaGen® HypoKit® may include rash, difficulty breathing, or low blood pressure (hypotension).
The most common side effects of GlucaGen® HypoKit® include nausea, vomiting, temporary fast heartbeat or pounding in your chest (tachycardia).
Tell your doctor if you have any side effect that bothers you or that does not go away. Please click here for the GlucaGen® HypoKit® Prescribing Information
http://www.novo-pi.com/glucagenhypokit.pdf and GlucaGen® HypoKit® Patient Information.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has more than 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.
John
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News Release
Paradise Valley Market, Inc. (Carnival Supermarket) Recalls Ground Beef Products due To Possible E. Coli O157:H7 Adulteration
Class I Recall
077-2016
Health Risk: High
Sep 8, 2016
Congressional and Public Affairs
Jeremy J. Emmert
(202) 720-9113
WASHINGTON, Sept. 8, 2016 – The Paradise Valley Market, Inc. (Carnival Supermarket), located at 870 3rd Avenue, Chula Vista, Calif., is voluntarily recalling approximately 35 pounds of ground beef products that may be adulterated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The lean and extra lean ground beef was produced and sold only on Sept. 1, 2016. The following products are subject to recall:
20-lbs. of 15% lean ground beef product. The product would have been packaged to order and sold at the Carnival Supermarket meat counter in reddish plastic bags with a tied knot at the top.
15-lbs. of 7% extra lean ground beef product. The product would have been packaged to order and sold at the Carnival Supermarket meat counter in reddish plastic bags with a tied knot at the top.
The problem was discovered when FSIS received notification that a product sample collected at the firm tested positive for E. coli O157:H7. There have been no confirmed reports of illness or 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 issued the voluntary recall over concerns 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 product 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 call Sandy Young, Vice President of J. Waltcher Communications, at (619) 296-7140.
John
close up of the batch number.
Recall: Chrysler Vehicles
in Pinching Pennies
Posted
http://www.komando.com/happening-now/373395/1-9-million-cars-recalled-for-defective-airbags?utm_medium=nl&utm_source=notd&utm_content=2016-09-16-article-title
*Snip*
The company announced that it's now recalling 1.9 million vehicles for another air bag defect that has already been linked to three fatalities and five injuries.
It turns out, the part of the car that deploys the airbag has a software problem the (that?) prevents the airbags from deploying "in certain rare circumstances."
Affected cars were sold between 2010 and 2014 and include the following models:
Chrysler Sebring
200
Dodge Caliber
Avenger
Jeep Patriot
Compass SUVs
In the meantime, you can check the official Chrysler-Fiat recall site and enter your vehicle's VIN number by clicking here.
http://recalls.mopar.com/