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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.
Roland Foods, LLC, Initiates A Voluntary Recall of Roland® Preserved Lemons Due to Undeclared Sulfites in Product
For Immediate Release
October 11, 2016
Contact
Consumers
Consumer Hotline
1-800-221-4030 ext. 222
Announcement
View Product Photos
New York, NY - Roland Foods, LLC in cooperation with the manufacturer in Morocco, is voluntarily recalling specific lots of Roland® Preserved Lemons due to undeclared sulfites in the product. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product.
The affected lots of Roland® Preserved Lemons were distributed nationwide and to Canada to food distributors, food service customers, and super market chains for further distribution or use.
The following product is subject to the voluntary recall:
• Product: Roland® Preserved Lemons
• Lot #: 20
• Item #: 61002 (on case label)
• UPC #: Item UPC 4122461002 and Case UPC 10041224610023
• Pack Size: NET WT. 12.35 OZ.; 12 glass jars per case
• Production Codes: DA: 169Z P: 0618 (ink jet printed on the jar lid)
and
• Product: Roland® PRESERVED LEMONS - BELDI
• Lot #: 21
• Item #: 61002 (on case label)
• UPC #: Item UPC 4122461002 and Case UPC 10041224610023
• Pack Size: NET WT. 13 OZ.; 12 glass jars per case
• Production Code: P: Q0303 (ink jet printed on the jar lid);
No other lots of Roland® Preserved Lemons are affected by this voluntary recall.
No illnesses have been reported to date.
The recall was initiated after the firm received a notification from the New York State Department of Agriculture and Markets that the product containing sulfites was distributed in packaging that did not reveal the presence of sulfites. Subsequent testing conducted by a private laboratory confirmed the presence of sulfites in the product. Roland Foods has notified the foreign manufacturer of the findings in order to conduct an investigation as to what caused the problem.
Consumers who have a sensitivity to sulfites and had purchased the affected Roland Preserved Lemons are urged not to consume the product and to return it to the place of purchase. Consumers can visit www.rolandfood.com, or contact its Consumer Hotline at 1-800-221-4030 ext. 222, Monday – Friday, 9 am -5 pm EST, for further information about the voluntary recall and for instructions on obtaining replacement product.
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.
Blue Bunny Hoppin’ Hollidoodle Ice Cream Voluntary Recall
For Immediate Release
October 10, 2016
Contact
Consumers
Consumer Affairs
1-800-331-0830
Media
Lesley Bartholomew
712-546-4000 Ext: 2038
Announcement
View Product Photos
Le Mars, Iowa - Wells Enterprises, Inc. is voluntarily recalling two lots of Blue Bunny Hoppin’ Holidoodle ice cream sold at retail outlets, because they contain snickerdoodle cookie dough pieces recalled by the supplier, Aspen Hills, due to potential contamination with Listeria monocytogenes. Wells has received no reports of illness attributable to this product.
Only Hoppin’ Holidoodle ice cream with the following lot numbers and best if used by dates are included in this recall. The recalled product is a seasonal holiday flavor with very limited geographic distribution in six states. Consumers should check the side of their ice cream packages to check for the following lot numbers and best if used by dates:
Product Name
Size
UPC, Lot #, Best Used by Date
States Distributed
Blue Bunny Hoppin’ Holidoodle Ice Cream
46 fluid ounces
UPC 070640014644
LOT 60001 MM 19115 6228
BEST IF USED BY 02/13/18
UPC 070640014651
(High altitude)
LOT 60001 MM 19115 6229
BEST IF USED BY 02/14/18
NE, OK, KS, MO, AZ,TX
No other Blue Bunny product is included in this recall.
Listeria monocytogenes is an organism that 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 monocytogenes infection can cause miscarriages and stillbirths among pregnant women.
Consumers with product matching lot numbers and best if used by dates should return the products to the retail outlets where purchased for a full refund. Anyone requiring more information should telephone Wells Enterprises, Inc. consumer affairs at 1-800-331-0830.
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.
Outside Supplier Aspen Hills Expands Cookie Dough Recall; Blue Bell Recalls All Products Made With Aspen Hills Cookie Dough Due To Potential Health Risk
For Immediate Release
October 10, 2016
Contact
Consumers
979-836-7977
Media
979-830-9830
Announcement
View Product Photos
BRENHAM, Texas – Blue Bell Ice Cream is voluntarily recalling all products that were made with a cookie dough ingredient supplied by a third party supplier Aspen Hills, Inc., due to the potential for them to contain Listeria monocytogenes. Listeria monocytogenes 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.
No illnesses have been reported to date. Blue Bell initiated this expanded recall after Aspen Hills provided additional information on affected cookie dough lots. Although our products in the marketplace have passed our test and hold program, which requires that finished product samples from a batch test negative for Listeria monocytogenes before the batch can be released, Blue Bell is initiating this recall out of an abundance of caution. This recall is being conducted in cooperation with the FDA.
This recall includes the following products in half gallons and pints, Blue Bell Chocolate Chip Cookie Dough and Blue Bell Cookie Two Step sold to retail outlets, and three gallon flavors sold to food service accounts including Blue Bell Blue Monster, Blue Bell Chocolate Chip Cookie, and Blue Bell Krazy Kookie Dough. These products were produced from February 2, 2016 through September 7, 2016.
The consumer and food service products produced with the cookie dough pieces were distributed in the following states Alabama, Arkansas, Florida, Georgia, Kansas, Kentucky, Louisiana, Mississippi, Missouri, New Mexico, North Carolina, Oklahoma, South Carolina, Tennessee, Texas and Virginia.
Consumers should not eat the recalled products and are encouraged to return them to the place of purchase for a full refund.
We continue to work closely with our regulatory agencies, and we remain committed to ensuring we are producing safe products for our consumers to enjoy. For more information, consumers with questions may call 979-836-7977, Monday – Friday 8 a.m. – 5 p.m. CST.
This is an expansion of the original recall posted here: Link to Blue Bell Recall
http://www.fda.gov/Safety/Recalls/ucm522045.htm
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.
Mars Petcare US Announces Voluntary Recall of Limited Number of CESAR® Classics Filet Mignon Flavor Wet Dog Food Because of Potential Presence of Plastic
For Immediate Release
October 7, 2016
Contact
Consumers
Mars Petcare US
800-421-6456
Media
Angel May
615-310-8229
Announcement
View Product Photos
Franklin, Tennessee – Today, Mars Petcare US announced a voluntary recall of a limited number of CESAR® Classics Filet Mignon Flavor product due to a potential choking risk from hard white pieces of plastic which entered the food during the production process. CESAR® Classics Filet Mignon can be purchased individually, as well as, in flavor variety multipacks. The Lot Codes listed below are the only affected products. All other CESAR® products can be safely consumed.
We encourage consumers who have purchased affected product to discard the food or return it to the retailer for a full refund or exchange. While a small number of consumers have reported finding the plastic pieces, to date, we have not received any reports of injury or illness associated with the affected product. The lot codes indicated below should not be sold or consumed.
Affected product was distributed to retail customers throughout the United States. Mars Petcare US is working with all of our distributors and retailers to ensure that the recalled products are no longer sold and are removed from inventory.
Recalled Pet Food
Two lot codes of CESAR® Classics Filet Mignon Flavor wet dog food with the production codes shown below are included in this voluntary recall. Each product will have a lot code printed on side of the tray that begins with 631FKKC, 631GKKC. A Best Before date 080418 (August 4, 2018) and 080518 (August 5, 2018).
UPC
DESCRIPTION
LOT CODES
23100017792
CESAR® CLASSICS FILET MIGNON FLAVOR
631FKKC and 631GKKC
The CESAR® Classics Filet Mignon Flavor can be found in variety packs with the following lot codes:
632D14JC, 633B24JC, 634A14JC, 634A24JC, 634B14JC, 634B24JC, 634E14JC, 635A24JC, 635B14JC, 636D24JC, 636E14JC
At Mars Petcare US, we take our responsibility to pets and their owners seriously. Pet owners who have questions about the recall should call 800-421-6456 between the hours of Saturday, October 8, 8:00 am to 12:00 pm CST and Monday through Friday 8:00 am to 4:30 pm CST or visit https://www.cesar.com/notice.
John
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Premature Battery Depletion of St. Jude Medical ICD and CRT-D Devices: FDA Safety Communication
Date Issued:
October 11, 2016
Audience:
Patients with a St. Jude Medical Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) device
Caregivers of patients with a St. Jude Medical ICD and CRT-D device
Cardiologists, electrophysiologists, cardiac surgeons, primary care physicians treating patients with heart failure or heart rhythm problems
Medical Specialties:
Cardiac Electrophysiology, Cardiology, Cardiac Surgery, Heart Failure
Device:
St. Jude Medical Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms.
ICDs and CRT-Ds are both implanted under the skin in the upper chest area with connecting insulated wires called “leads” that go into the heart. Patients need an ICD or CRT-D if their heart beat is too slow (bradycardia), too fast (tachycardia), or needs coordination to treat heart failure.
The devices addressed in this communication are the following St. Jude Medical ICD and CRT-D models manufactured before May 2015:
Fortify VR
Fortify ST VR
Fortify Assura VR
Fortify Assura ST VR
Fortify DR
Fortify ST DR
Fortify Assura DR
Fortify Assura ST DR
Unify
Unify Quadra
Unify Assura
Quadra Assura
Quadra Assura MP
Purpose:
FDA is providing information and recommendations regarding St. Jude Medical’s advisory on ICD and CRT-D batteries that may fail earlier than expected. FDA and St. Jude Medical are alerting patients, patient-caregivers, and physicians to respond immediately to Elective Replacement Indicator (ERI) alerts. Due to problems with these batteries, patients do not have the normal 3-month lead time for device replacement. Some batteries have run out within 24 hours of the patient receiving an ERI alert. St. Jude Medical has initiated a recall and correction of the affected devices.
Summary of Problem and Scope:
Implanted defibrillators (ICDs and CRT-Ds) are powered by lithium-based batteries. Deposits of lithium, known as “lithium clusters,” can form within the battery and create abnormal electrical connections leading to rapid battery failure.
St. Jude Medical has reported that in some cases, full battery drainage can occur within a day to a few weeks after the patient receives an ERI alert. If the battery runs out, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death. The patients most at risk are those with a high likelihood of requiring life-saving shocks and those who are pacemaker dependent.
To date, of the 398,740 affected devices sold worldwide, 841 were returned for analysis due to premature battery depletion caused by lithium clusters.
2 deaths (1 in the U.S.), have been associated with devices that could not provide needed shock therapy due to premature battery depletion.
10 patients (9 in the U.S.), have reported fainting from devices that could not provide needed pacing therapy due to premature battery depletion.
37 patients (30 in the U.S.), have reported dizziness from devices that could not provide needed pacing therapy due to premature battery depletion.
Battery depletion may not always be reported to the manufacturer, therefore the true number of devices with premature battery depletion due to lithium clusters is not known. At this time, 349,852 affected devices remain actively implanted worldwide.
Devices may be programmed to deliver a vibratory patient alert when the battery has reached ERI. In addition, St. Jude Medical’s home monitoring system may be used to monitor battery status and provide health care provider notifications. Due to the low frequency of device failure, these are likely appropriate mitigations for most patients, as patients could be at greater risk of complications from the surgical procedure required to replace the device.
However, because battery depletion may occur rapidly after an ERI, and some patients may not detect the device alert, these mitigations may not be sufficient for all patients, such as those that are dependent upon their device for pacing with an untolerated or absent intrinsic heart rate. Health care providers should consider whether elective device replacement is warranted for their pacemaker dependent patients.
Ultimately, health care providers should individualize the care of their patients based on the patients’ medical history, comorbidities and condition.
Recommendations for Health Care Providers:
Do not implant unused affected devices. Premature battery depletion due to lithium clusters has only been observed in devices manufactured prior to May 2015. At this time, there is no information indicating that this issue affects devices manufactured after this date.
Communicate with all patients who have an affected device that their device has a battery that may run out earlier than expected. Consider giving patients the Dear Patient letter provided by St. Jude Medical.
Continue to conduct follow-up on patients with affected devices using in-office visits in addition to remote monitoring once they have been notified of the battery issue. Increased in-office surveillance is not necessary for patients who are also followed with remote monitoring.
Immediately replace the device at the time of an ERI alert. Currently, there is not a factor, method, or test to identify when devices with this form of premature battery depletion are approaching ERI, or to accurately predict remaining battery life once ERI appears.
Pacemaker-dependent patients with a device that has reached ERI should be treated as a medical emergency.
Health care providers should consider whether elective device replacement is warranted for their pacemaker dependent patients. Ultimately, health care providers should individualize the care of their patients based on the patients’ medical history, comorbidities and condition.
Most patients will not require prophylactic device replacement prior to ERI, as the rate of complications following replacement surgery are higher than those associated with premature battery depletion. However, the FDA and St. Jude Medical recognize the need to weigh individual clinical considerations. If the decision is made to replace an affected device based on individual patient circumstances, St. Jude Medical has announced they will provide a replacement device at no cost.
Enroll patients in Merlin@Home, St. Jude Medical’s home monitoring system for these devices, especially those who have difficulty recognizing their device’s ERI alerts. For patients already enrolled in Merlin@Home, explain the importance of ongoing home monitoring. Utilize the “Direct Alerts” feature to provide you with an alert notification when a patient’s device has reached ERI. Please see additional information about the Merlin@Home Monitoring System below. If a home monitor is ordered for a patient with an affected device, St. Jude Medical will cover the cost of the home monitor.
Ensure that the ERI battery alert is ON for all patients. Review the most recent “Programmed Parameters” printout.
Review the “Trigger Alerts When” section, and ensure that the “Device at ERI” parameter is “On” for both the “Show on FastPath” and “Notify Patient” selections.
If the “Device at ERI” alert is “Off”, the patient should be seen promptly to program this parameter to “On”.
Advise affected patients that an ERI alert triggers a vibratory notification, and perform the following procedures at each scheduled office visit:
Interrogate the patient’s device to determine if an ERI alert has been triggered. Premature battery depletion can be identified by health care providers through home monitoring showing ERI or more advanced battery depletion.
Perform a patient notifier test to confirm that the patient feels and recognizes the vibratory alert.
Patients who cannot feel the vibratory alert may experience loss of battery and/or loss of device function without their awareness.
Advise the patient to contact your office promptly should they feel a vibratory alert. An in-office evaluation should be performed to determine the reason for the alert as other non-critical events can also trigger a vibratory alert.
Recommendations for Patients and Caregivers:
Contact your physician if you feel a vibratory alert. St. Jude Medical ICD and CRT-D devices are designed to deliver a vibratory alert to you when the battery is nearing its end of life. Immediately contact your physician if you feel the device’s vibratory battery alert. Devices affected by this advisory may reach end of battery life anywhere from within one day to several weeks after the vibratory alert has been delivered. If the device does deliver a vibratory alert due to low battery, it will need to be replaced.
Register for home monitoring. St. Jude Medical devices are capable of home monitoring, which can alert your physician to a notification that the battery is approaching end of life. If you do not already use home monitoring for your device, and especially if you have difficulty recognizing your device’s end of battery alerts, you and your physician should consider whether home monitoring is appropriate for you. Please see additional information about the Merlin@Home Monitoring System below.
Seek immediate medical attention if you have symptoms of lightheadedness, dizziness, loss of consciousness, chest pain, or severe shortness of breath. These may be signs of a depleted battery.
Management of your implanted device and your medical condition must be individualized. You should consult with your health care provider to determine the best course of action.
Merlin@Home Monitoring System:
At this time, the FDA recommends that patients, patient caregivers, and health care providers enroll in and utilize the St. Jude Medical Merlin@Home monitoring system to help detect battery depletion. The FDA is investigating cybersecurity concerns associated with these devices, including the Merlin@Home.
The FDA (in partnership with the Department of Homeland Security ICS-CERT) continues to investigate recent allegations of cybersecurity vulnerabilities associated with St. Jude Medical cardiac devices, including the Merlin@Home monitoring system. Despite the allegations, at this time, the FDA strongly recommends that the Merlin@Home device be used to monitor the battery for these affected devices. The ICD and CRT-D devices identified in this safety communication provide life-saving therapy, and the FDA believes that the benefits of monitoring outweigh any potential cybersecurity vulnerabilities.
FDA Actions:
The FDA will continue to monitor affected St. Jude Medical ICD and CRT-D devices for any adverse events related to premature battery depletion or cybersecurity vulnerabilities, and the agency will keep the public informed as new information becomes available.
Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks related to the use of medical devices. If you suspect or experience a problem with these devices, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Additional Resources:
St. Jude Medical – Premature Battery Depletion Information
Contact Information:
If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.
John
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FSIS Issues Public Health Alert for Chicken Product Due to Possible Salmonella Contamination
Congressional and Public Affairs
Gabrielle N. Johnston
(202) 720-9113
WASHINGTON, Oct. 9, 2016 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert out of an abundance of caution due to concerns about illnesses caused by Salmonella that may be associated with a chicken salad product sold from Costco Store #1190, in Lynwood, Wash.
The chicken salad item for this public health alert was produced Aug. 26 through Sept. 2, 2016. The following product is subject to the public health alert:
Label
Varying weights of “Costco Rotisserie Chicken Salad”.
This product was sold directly to consumers who shopped at Costco Store #1190 in Lynwood, Wash.
On September 26, 2016, the Centers for Disease Control and Prevention (CDC) notified FSIS of an investigation of Salmonella I 4,[5],12:i:- illnesses in the state of Washington. Working in conjunction with CDC and the Washington State Department of Health, FSIS determined that there is a possible link between rotisserie chicken salad from Costco’s Alderwood store in Lynwood, Wash. and these illnesses. Based on epidemiological evidence, four Salmonella I 4,[5],12:i:- case-patients have been identified with illness onset dates ranging from September 2 to September 6, 2016. Traceback investigation indicated that three of these case-patients consumed rotisserie chicken salad purchased on August 26, August 31 and September 2, 2016 from this Costco location. No product has tested positive for this strain of Salmonella. Clinical isolates associated with this investigation were tested for antibiotic-resistance, and three isolates from Washington State were found resistant only to tetracycline and susceptible to other antibiotics commonly used to treat salmonellosis. FSIS continues to work with Costco and public health partners on this investigation, and will provide more information as it becomes available.
Consumption of food contaminated with Salmonella can cause salmonellosis, one of the most common bacterial foodborne illnesses. The most common symptoms of salmonellosis are diarrhea, abdominal cramps, and fever within 12 to 72 hours after eating the contaminated product. The illness usually lasts 4 to 7 days. Most people recover without treatment. In some persons, however, the diarrhea may be so severe that the patient needs to be hospitalized. Older adults, infants, and persons with weakened immune systems are more likely to develop a severe illness. Individuals concerned about an illness should contact their health care provider.
FSIS and the company are concerned that some product may be frozen and in consumers' freezers.
Consumers who have purchased this product on August 26, August 31 and September 2, 2016 are urged not to consume it. This product should be thrown away or returned to the place of purchase.
FSIS advises all consumers to safely prepare their raw meat products, including fresh and frozen, and only consume rotisserie chicken that has been cooked to a temperature of 165° F. The only way to confirm that rotisserie chicken 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.
Recommendations for Preventing Salmonellosis:
Wash hands with warm, soapy water for at least 20 seconds before and after handling raw meat and poultry. Also wash cutting boards, dishes and utensils with hot soapy water. Clean up spills right away.
Keep raw meat, fish and poultry away from other food that will not be cooked. Use separate cutting boards for raw meat, poultry and egg products and cooked foods.
Cook raw meat and poultry to safe internal temperatures before eating. The safe internal temperature for meat such as ground beef and pork is 160º F, and 165º F for poultry, as determined with a food thermometer.
Refrigerate raw meat and poultry within two hours after purchase (one hour if temperatures exceed 90º F). Refrigerate cooked meat and poultry within two hours after cooking.
John
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News Release
Kraft Heinz Recalls Ready-To-Eat Lunchables Ham and American Cracker Stackers Product Due to Misbranding and Undeclared Allergens
Class I Recall
093-2016
Health Risk: High
Oct 9, 2016
Congressional and Public Affairs
Sarah R. Lichtman
(202) 720-9113
WASHINGTON, Oct. 9, 2016 – Kraft Heinz Company, a Fullerton, Calif. establishment, is recalling approximately 959 pounds of ready-to-eat “Lunchables Ham and American Cracker Stackers” packaged lunch 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 wheat and soy, known allergens, which are not declared on the product label.
The ready-to-eat meat and cheese packaged lunch items were produced on September 21, 2016. The following products are subject to recall:
View Labels PDF only
3.4-oz. boxes containing four-compartment plastic trays of “Lunchables Ham and American Cracker Stackers,” with a “USE BY” date of 25 DEC 2016 and production times ranging from 9:13 to 10:00 stamped on the side of the plastic container.
The products subject to recall bear establishment number “EST. 537K” inside the USDA mark of inspection. These items were shipped to retail locations in Utah and California.
The problem was discovered on October 6, 2016, when the firm received a consumer complaint. There were no illnesses associated with the complaint.
The establishment determined that the “Lunchables Ham and American Cracker Stackers” products were incorrectly labeled with the back label for a “Nacho Lunchable” product. The back label contains the product ingredient statements and as such, the “Lunchables Ham and American Cracker Stackers” products that were mislabeled do not declare wheat and soy on the label.
There have been no confirmed reports of adverse reactions due to consumption of this product. Anyone concerned about an injury or illness should contact a healthcare provider.
Consumers who have purchased this product are urged not to consume it. This product should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Consumers with questions about the recall can contact the Kraft Heinz Consumer Relations Center, at 1-800-573-3877. Members of the media with questions about the recall can contact Lynne Gaila, Corporate Affairs Director, Kraft Heinz Company, at (847) 646-4396 or lynne.galia@kraftheinzcompany.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.
Osage Gardens Inc. Recalls Osage Gardens Organic 2oz Micro Greens Because of Possible Health Risk
For Immediate Release
October 7, 2016
Contact
Consumers
Jared McDermott
970-876-0668
Announcement
View Product Photos
New Castle, CO - Osage Gardens Inc. is recalling Osage Gardens Organic 2oz Micro Greens, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
Osage Gardens Organic 2oz Micro Greens was distributed to Whole Foods stores in Colorado and Kansas. The Osage Gardens Organic 2oz Micro Greens product is packed in a clear plastic clamshell and has a label on the bottom with a UPC Code 709376615008 and affected product are dated with a Julian codes from 266 to 279’.
No illnesses have been reported to date.
The recall was a result of a routine sampling by the FDA which revealed that the finished products contained the bacteria. Osage Gardens Inc. has ceased the production and distribution of the product as FDA and Osage Gardens Inc. continue their investigation as to what caused the problem.
Consumers who have purchased Osage Gardens Organic 2oz Micro Greens are urged to return it to the place of purchase for a full refund. Consumers with questions may contact Osage Gardens Inc. at 970-876-0668 Monday-Friday 8am-4:30pm.
John
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*Snip
Shellfish from Maine have been recalled after samples tested positive for high levels of a dangerous neurotoxin.
The recall notice, issued by the Maine Department of Marine Resources, applies to mussels and mahogany quahogs (another name for clams) that were harvested or wet-stored in the Jonesport area between September 25 and September 30; as well as clams harvested between Cranberry Point in the town of Corea to Cow Point in Roque Bluffs between September 28 and September 30.
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.
Osage Gardens Inc. Recalls Osage Gardens Organic 2oz Micro Greens Because of Possible Health Risk
For Immediate Release
October 7, 2016
Contact
Consumers
Jared McDermott
970-876-0668
Announcement
View Product Photos
New Castle, CO - Osage Gardens Inc. is recalling Osage Gardens Organic 2oz Micro Greens, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
Osage Gardens Organic 2oz Micro Greens was distributed to Whole Foods stores in Colorado and Kansas. The Osage Gardens Organic 2oz Micro Greens product is packed in a clear plastic clamshell and has a label on the bottom with a UPC Code 709376615008 and affected product are dated with a Julian codes from 266 to 279’.
No illnesses have been reported to date.
The recall was a result of a routine sampling by the FDA which revealed that the finished products contained the bacteria. Osage Gardens Inc. has ceased the production and distribution of the product as FDA and Osage Gardens Inc. continue their investigation as to what caused the problem.
Consumers who have purchased Osage Gardens Organic 2oz Micro Greens are urged to return it to the place of purchase for a full refund. Consumers with questions may contact Osage Gardens Inc. at 970-876-0668 Monday-Friday 8am-4:30pm.
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.
Nestlé USA Initiates Voluntary Recall Of Nestlé® Drumstick® Club 16 Count Variety and 24 Count Vanilla Pack Due to Possible Health Risk
For Immediate Release
October 7, 2016
Contact
Consumers
Customer Service
1-800-681-1676
Announcement
View Product Photos
Glendale, CA - Nestlé USA, Inc. is initiating a voluntary recall of its Nestlé Drumstick Club 16 count Variety Pack and 24 count Vanilla Pack (with cones marked for easy individual sale) due to a possible health risk. The two pack sizes contain 4.6 fl.oz. cones and were manufactured in Bakersfield, Calif. and distributed nationally. No other production codes, sizes or varieties of Nestlé Drumstick products are affected by this recall.
The company received positive test results for Listeria monocytogenes (LM) from equipment contact surfaces from a location on the production line where these products are made. There have been no positive test results for LM present in the Drumstick cones themselves. The products impacted by the voluntary recall were put into distribution inadvertently. No illnesses have been reported to date; the company is initiating this recall as a precautionary action to avoid any potential for consumer illness.
Listeria monocytogenescan 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 Nestlé recall is limited to the Drumstick Club 16 Count Variety Pack and 24 count Vanilla Pack, made at the company’s Bakersfield, Calif. ice cream production facility. The product identification codes can be found on the back of the packages and on the individually marked vanilla cones from the 24 count pack. The two packs being recalled carry distinct UPC codes, as well as a “best before” date and production code.
Description
Production Code
UPC
Best Before Date
DSTK Club CP 16x4.6floz US
6244580212
6245580212
6246580212
6247580212
6248580212
6249580212
6250580212
6251580212
6252580212
6253580212
6254580212
6255580212
6256580212
6257580212
72554-11096
Between June 2 - June 15, 2017
DSTK Vanilla 24x4.6floz US
6258580212
6259580212
6260580212
6261580212
72554-00160
Between June 16 - June 19, 2017
Consumers who may have purchased the product listed above should not consume it, but instead should return it to the place of purchase or contact Nestlé Consumer Services for replacement. Please call or text 1-800-681-1676 or email Nestleproductinquiry@casupport.com; representatives are available 24/7. News about this recall also can be found on Nestléusa.com and Drumstick.com.
The quality and safety of Nestlé products remain our number one priority. We apologize for any inconvenience this action represents for both our consumers and retail customers.
John
-
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.
Le Petit Belge, LLC Issues Allergy Alert on Undeclared Milk in Belgian Boys Mini Pancakes
For Immediate Release
October 7, 2016
Contact
Consumers
Customer Service
1-631-393-3621
Announcement
View Product Photos
Brooklyn, NY - Le Petit Belge, LLC is voluntarily recalling 480 cases of Belgian Boys Mini Pancakes, Lot 20432, because it may contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
The affected lot of BELGIAN BOYS MINI PANCAKES was sold from June 2016 through the end of September 2016 to distributors located in Texas, Maryland, California, Illinois, and Canada for further distribution to retail stores.
BELGIAN BOYS MINI PANCAKES are packaged in a 10.6 oz./300 g box with UPC 857290005204, Lot 20432 (located on lower front box panel), and Best Before Jul 07 2017 code (located on the bottom flap). There are 12 boxes packed in a case. The products were manufactured and imported from The Netherlands.
One illness has been reported to date in Canada.
The recall was initiated after it was discovered that product containing milk was distributed in packaging that did not reveal the presence of milk. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes. The company and foreign manufacturer continue its investigation into the cause of the problem.
Consumers who have purchased Belgian Boys Mini Pancakes that are allergic to milk are urged no to consume it and to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-631-393-3621, Monday - Friday, 9 am - 4 pm, ET.
John
-
News Release
Silver Springs Farms, Inc. Recalls Beef Products Due To Possible E. Coli O157:H7 Adulteration
Class I Recall
091-2016 EXP
Health Risk: High
Oct 7, 2016
Congressional and Public Affairs
Allie Ryan
Sarah R. Lichtman
(202) 720-9113
EDITOR’S NOTE: This release is being reissued as an expansion of the Sept. 30, 2016, release to include additional product produced from and/or commingled with the source material implicated in the original recall. The original recall included 740 pounds of ground beef products. This expansion includes an additional 7,230 pounds of ground beef patties and burgers, and an undetermined amount of various sandwich steak products.
WASHINGTON, Oct. 7, 2016 – Silver Springs Farms, Inc., a Harleysville, Pa. establishment is recalling approximately 7,970 pounds of ground beef and burger products, as well as an undetermined amount of sandwich steak 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 ground beef items were produced on August 19 and 20, 2016. The exact production dates for the various sandwich steak products are unknown at this time, but are believed to have been produced between August 19 and September 19, 2016. The following products are subject to recall:
View Labels PDF only
20-lb. cases containing 4 packages of 5-lb ground beef 80/20.
10-lb. packages of “Camellia Beef Pattie 80/20,” with package codes 6235 and 6242.
10-lb. packages of “Silver Springs Farm Beef Pattie 80/20,” with package codes 6242 and 6237.
10-lb. packages of “Silver Springs Farm Beef Pattie 80/20 Flat,” with package code 6237.
10-lb. packages of “Silver Springs Farm Gourmet Beef Burger Flat,” with package code 6235.
10-lb. packages of “Silver Springs Farm Gourmet Beef Burger 80/20,” with package code 6237.
10-lb. packages of “Silver Springs Farm Gourmet Beef Pattie 80/20,” with package code 6242.
Various sandwich steak products produced by the recalling firm.
The products subject to recall bear establishment number “EST. 4771” inside the USDA mark of inspection. These items were shipped to a distributor in Virginia and institutional food establishments in New York, Pennsylvania and Maryland.
The problem was discovered during a routine verification sampling performed by Silver Springs Farms, Inc. 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 are concerned that some product may be frozen and in consumers' freezers.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
FSIS advises all consumers to safely prepare their raw meat products, including fresh and frozen, and only consume ground beef that has been cooked to a temperature of160° F. The only way to confirm that ground beef is cooked to a temperature high enough to kill harmful bacteria is to use a food thermometer that measures internal temperature, http://1.usa.gov/1cDxcDQ.
Media and consumers with questions regarding the recall can contact Dan Fillippo, Owner, Silver Springs Farms, Inc., at (215) 256-4321.
John
-
https://www.cpsc.gov/Recalls/2017/Interlogix-Recalls-to-Inspect-Personal-Panic-Devices
Interlogix Recalls to Inspect Personal Panic Devices Due to Failure to Operate in an Emergency
Recall date: October 4, 2016
Recall number: 17-004
Recall Summary
Name of product: Interlogix ® wireless personal panic devices
Hazard: The wireless personal panic devices can fail to operate, which could result in the device not communicating with the security system if activated in the event of an emergency.
Consumer Contact:
Consumer Contact: Interlogix at 800-394-4988 Monday through Friday, from 8 a.m. to 8 p.m. PT, email at questions@interlogix.com, or online at www.interlogix.com and click on Customer Service for more information.
Recall Details
Units:
Units: About 67,000
Incidents/Injuries:
None reported
Remedy:
Consumers should immediately contact their professional security system installer or monitoring company for a free inspection of their personal panic device and a free replacement device for those that fail inspection.
Sold At:
Through professional security installers and distributors nationwide from May 2014 through January 2016 for about $35 to $50.
Manufacturer(s):
Interlogix, of Lincolnton, NC
Manufactured In:
Mexico
John
-
https://www.cpsc.gov/Recalls/2017/Office-Depot-Recalls-Winsley-Chairs
Office Depot Recalls Winsley Chairs Due to Fall Hazard
Recall date: October 4, 2016
Recall number: 17-006
Recall Summary
Name of product: Winsley Mid-Back Chairs
Hazard: The chair can tip over when leaning back, posing a fall hazard.
Consumer Contact:
Office Depot at 800-949-9974 from 8 a.m. to 8 p.m. ET Monday through Friday, or visit the firm's website at www.officedepot.com/ and click on Recall Notices at the bottom of the page for more information.
Recall Details
Units:
About 129,000
Incidents/Injuries:
None reported
Remedy:
Consumers should immediately stop using the recalled chair and contact Office Depot to receive a free repair kit.
Sold At:
Office Depot and OfficeMax stores nationwide and online at officedepot.com from August 2015 through August 2016 for about $150.
Importer(s):
Office Depot, Inc., of Boca Raton, Fla.
Distributor(s):
Office Depot, Inc., of Boca Raton, Fla.
Manufactured In:
China
John
-
Yep, I'd eat them.
John
-
www.cnn.com/2016/10/06/health/summer-infant-bathtub-recall/index.html
*Snip
Summer Infant, a baby product brand, has issued a voluntary recall of 86,000 fabric slings that are attached to Lil' Luxuries Whirlpool, Bubbling Spa & Shower bathtubs.
The recalled slings are missing a white plastic clip that connects the headrest area of the fabric to the frame of the bathtub, causing the material to slip down the tub's side. The lack of an attachment poses an injury and drowning risk to babies, the company says.
The recalled sling and tub sets were sold between October 2012 and October 2013, and they have the following item numbers: 18840, 18850, 18863 and 18873. The manufacture date of the item is listed as a four-digit code, with the two-digit year followed by the month, such as "1212" for December 2012.
If your infant bathtub does not have a clip, you can fill out a form on Summer Infant's website, Summerinfant.com, to receive a replacement sling.
John
-
http://www.emergencyemail.org/newsemergency/anmviewer.asp?a=6662&z=63
RECALL: Craft Paints
Sargent Art Recalls Craft Paints Due to Risk of Exposure to Bacteria
Recall date: October 4, 2016
Recall number: 17-003
Recall Summary
Name of product: Arts and crafts tempera and finger paints
Hazard: The paint can contain harmful bacteria. Exposure to certain bacteria can have adverse health effects in immunocompromised individuals, posing a risk of serious illness including a bacterial infection. Consumers with healthy immune systems are not generally affected by the bacteria.
Remedy: Refund
Consumer Contact:
Sargent Art at 800-827-8081 from 9 a.m. to 5 p.m. ET and Monday through Friday, or online at www.sargentart.com and click on "Recall" for more information.
Units:
About 2.8 million units of paint in the U.S. (in addition, 20,000 units in Canada)
Description:
This recall involves 13 types of Sargent Art tempera and finger paints. All colors and sizes of the following types of Sargent Art paints are included in the recall:
Art-Time Tempera Paint
Liquid Tempera Paint
Art-Time Washable Finger Paint
Supreme Tempera Paint
Art-Time Washable Fluorescent Finger Paint
Value Tempera Paint
Art-Time Washable Fluorescent Tempera Paint
Washable Finger Paint
Art-Time Washable Glitter Finger Paint
Washable Glitter Paint
Art-Time Washable Paint
Washable Tempera Paint
Fluorescent Tempera Paint
Incidents/Injuries:
None reported
Remedy:
Consumers should immediately stop using the recalled paints and contact Sargent Art for a full refund.
Sold At:
Hobby Lobby, Walmart and other stores nationwide and online at Amazon.com and ShopSargentArt.com from May 2015 to June 2016 for between $1 and $8.
Manufacturer(s):
Sargent Art, of Hazleton, Pa.
Manufactured In:
U.S.A
John
-
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.
Vascular Solutions, Inc. Issues Recall of Twin-Pass® Dual Access Catheters
For Immediate Release
October 4, 2016
Contact
Phil Nalbone
VP of Corporate Development
(763) 656-4371
Announcement
On September 16, 2016, Vascular Solutions, Inc. (Nasdaq:VASC), http://www.globenewswire.com/Search?runSearchId=36355125
initiated a nationwide recall of Twin-Pass Dual Access catheters used in catheterization procedures. All unexpired lots of the product have been recalled because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. It is possible that the excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death. No injuries have been reported in association with this issue to date.
Healthcare facilities that have the affected Twin-Pass dual access catheters should remove the products from their inventory and return them to Vascular Solutions.
The recalled products were manufactured from October 2014 to August 2016 and distributed from October 2014 to September 2016.
The recalled products are all unexpired lots of Model Numbers 5200, 5210, and 5230. A listing of the recalled lots is available from Vascular Solutions and has been provided to each facility that purchased the affected products. A total of 15,896 devices have been manufactured, with 5,784 distributed in the United States and currently unexpired. The condition that led to the recall may affect approximately 9.2% of recalled devices.
Vascular Solutions, Inc. voluntarily initiated the recall on September 16, 2016 through an Urgent Medical Device Recall notification distributed to purchasers of the affected products. The notification identified the specific unexpired lots subject to the recall and included instructions on how to return the affected products.
The U.S. Food and Drug Administration (FDA) classified this as a Class I recall. FDA defines Class I recalls as “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
Consumers with questions may contact the company by phone at 1-888-240-6001 Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time or by email at customerservice@vasc.com. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program:
Online at http://www.fda.gov/medwatch/report.htm
(form available to fax (1-800-FDA-0178) or mail), or
Call FDA 1-800-FDA-1088 to request a reporting form
About Vascular Solutions
Vascular Solutions, Inc. is an innovative medical device company that focuses on developing unique clinical solutions for coronary and peripheral vascular procedures. The company has launched more than 100 products that are sold to interventional cardiologists, interventional radiologists, electrophysiologists, and vein specialists through its direct U.S. sales force and international independent distributor network.
For further information, connect to www.vasc.com
John
-
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.
Nurse Assist Initiates Nationwide Voluntary Recall of All Unexpired Lots of I.V. Flush Syringes
For Immediate Release
October 4, 2016
Contact
Consumers
Nurse Assist, Inc.
ProductRemovalInfo@nurseassist.com
1-800-649-6800 ext. 10
Media
Nurse Assist, Inc.
(800) 649-6800
Announcement
View Product Photos
Haltom City, TX – Nurse Assist, Inc. announced today that it is voluntarily recalling all unexpired lots of I.V. Flush Syringes due to a potential link to Burkholderia cepacia bloodstream infections with the product. According to the U.S. Centers for Disease Control and Prevention (CDC), the effects of Burkholderia cepacia on people “vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis.” If a patient is having symptoms, contact your health care provider.
Since patient safety is of utmost importance, all unexpired lots of these products are being recalled until a thorough investigation can be completed. There are no other related recalls for Nurse Assist products.
The recall affects the following lots and part numbers:
Product Code
Product Description
Lot Number
1203
IV Flush Syringe, 3ml fill
All unexpired lots
1205
IV Flush Syringe, 5ml fill
All unexpired lots
1210
IV Flush Syringe, 10ml fill
All unexpired lots
1210-BP
IV Flush Syringe, 10ml fill
All unexpired lots
Product Numbers 1203, 1205, and 1210 are packaged 30 syringes to an inner carton and six inner cartons in a case (180 syringes). For product number 1210-BP, 100 syringes are packaged in an inner carton with four inner cartons in a case (400 syringes). Lot code information can be found on the outer case panel, the back panel of the inner carton, and on each syringe label.
The lots being recalled were distributed to customers and distributors between 02/16/16 and 09/30/16. Product can be identified by the labeling on the packaging and device. Nurse Assist is directing customers not to use the product from recalled lots. Recalled product should be returned for credit by contacting Nurse Assist Customer Service at 1-800-649-6800 ext. 10, Monday through Friday, between the hours of 8am and 5pm, Central Time.
Nurse Assist voluntarily recalled its I.V. Flush Syringes after becoming aware of patients that developed Burkholderia cepacia bloodstream infections while receiving intravenous care using prepackaged saline flushes from Nurse Assist
Nurse Assist is notifying its distributors and customers via email, phone call, and certified mail. Customers will receive instructions for returning product. For freight collect shipping information, please contact the Customer Service Team at 1-800-649-6800 ext. 10.
Nurse Assist is actively investigating the possible link to the infections with the Food and Drug Administration, the U.S. Centers for Disease Control, and various state health departments to ensure that the products are safe for their intended use. Until an investigation can be completed, Nurse Assist urges all healthcare facilities with affected product to discontinue use and return the product to the supplier.
Consumers with questions may contact the company via telephone at 1-800-649-6800 ext. 10, Monday through Friday, between the hours of 8am and 5pm, Central Time. Consumers may also contact the company via email at ProductRemovalInfo@nurseassist.com.
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.
John
-
MedWatch
The FDA Safety Information and Adverse Event Reporting Program
Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating
AUDIENCE: Infectious Disease, Gastroenterology, Patient
ISSUE: The FDA is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death. HBV reactivation usually occurred within 4-8 weeks.
As a result, FDA is requiring a Boxed Warning, our most prominent warning, about the risk of HBV reactivation to be added to the drug labels of these DAAs directing health care professionals to screen and monitor for HBV in all patients receiving DAA treatment. This warning will also be included in the patient information leaflet or Medication Guides for these medicines.
BACKGROUND: Direct-acting antiviral medicines are used to treat chronic hepatitis C virus (HCV) infection, an infection that can last a lifetime. These medicines reduce the amount of HCV in the body by preventing HCV from multiplying, and in most cases, they cure HCV. Without treatment, HCV can lead to serious liver problems including cirrhosis, liver cancer, and death (see List of Direct-Acting Antivirals in the FDA Drug Safety Communication).
FDA identified 24 cases of HBV reactivation reported to FDA and from the published literature in HCV/HBV co-infected patients treated with DAAs during the 31 months from November 22, 2013 to July 18, 2016. This number includes only cases submitted to FDA, so there are likely additional cases about which FDA is unaware. Of the cases reported, two patients died and one required a liver transplant. HBV reactivation was not reported as an adverse event in the clinical trials submitted for the DAA approvals because patients with HBV co-infection were excluded from the trials. See the data summary section in the Drug Safety Communication for more detailed information.
RECOMMENDATION: Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with DAAs, and monitor patients using blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow-up.
Patients should tell your health care professional if you have a history of hepatitis B infection or other liver problems before being treated for hepatitis C. Do not stop taking your DAA medicine without first talking to your health care professional. Stopping treatment early could result in your virus becoming less responsive to certain hepatitis C medicines. Read the patient information leaflet or Medication Guide that comes with each new prescription because the information may have changed. Contact your health care professional immediately if you develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of serious liver problems.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
John
-
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.
Good Earth Egg Company Voluntarily Recalls Shell Eggs Because of a Possible Health Risk
For Immediate Release
October 3, 2016
Contact
Consumers
Good Earth Egg Company, LLC
Announcement
Good Earth Egg Company, LLC of Bonne Terre, Missouri has announced a voluntary recall of its shell eggs because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
The Food and Drug Administration has notified Good Earth Egg that a link has been established between eggs distributed by our facility to cases of Salmonella illnesses in Missouri and surrounding states.
In light of this investigation, and with an abundance of caution, Good Earth Egg Company has initiated a voluntary recall of all shell eggs. Various sizes of shell eggs are packaged in the following ways: 6-count cartons, 10-count cartons, 12-count cartons, 18-count cartons, 15 dozen cases, and 30 dozen cases. The dates and codes on the cartons and cases will include everything prior to and including date code 252 – Sell By 10/08/2016, with “Packed for” or “Produced for Good Earth Egg Company”
The Good Earth Egg Company recalled products were distributed throughout the Midwest, including Missouri, Illinois and Kansas, at the retail and wholesale level, institutions, restaurants and to walk-in customers. Good Earth eggs were sold at Dierbergs, Straubs, Midtowne Market and Price Chopper in the metropolitan St. Louis area.
Good Earth Egg Company is working with distributors and retailers to remove these products from wholesale suppliers and retail shelves. Consumers do not need to return the product to the store where it was purchased. Instead, consumers should discard any product and its container. Good Earth Egg Company will work directly with each consumer to manage replacement of its product.
Consumers with questions may contact Good Earth Egg Company, LLC at goodeartheggco@hotmail.com.
Good Earth Egg Company has released the following statement, “We are taking these steps because consumer safety is our top priority. As a third-generation family operated farm, we are solely focused on providing fresh, quality, healthy eggs to local consumers. Although no Good Earth Egg Company eggs have tested positive for Salmonella, we feel strongly that issuing a voluntary recall is the right thing to do. Good Earth Egg Company is working closely with the FDA to determine the root cause of the potential contamination.”
John
-
News Release
Daily's Premium Meats, LLC Recalls Bacon Products Due to Possible Listeria Adulteration
Class I Recall
092-2016
Health Risk: High
Oct 3, 2016
Congressional and Public Affairs
Nina Anand
(202) 720-9113
WASHINGTON, Oct. 3, 2016 – Daily’s Premium Meats, LLC, a Salt Lake City, Utah establishment, is recalling approximately 170 pounds of ready-to-eat bacon products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The “Regular Ends Precooked Bacon” items were produced on September 22, 2016. The following products are subject to recall:
View Labels PDF only
17 CASES of 2-5 lbs. PACKAGES IN CARDBOARD BOXES, CONTAINING “48108 REGULAR ENDS PRECOOKED BACON NET WT. 10 lbs. 2/5 lbs.” with a packaging date of “9/22/16” and use by date of “6/19/17.
The products subject to recall bear establishment number “EST. 6133” inside the USDA mark of inspection. These items were shipped to Associated Foods retail locations in Idaho and Utah.
The problem was discovered during the company’s routine internal third party testing when a product sample collected tested positive for Listeria monocytogenes (Lm). There have been no confirmed reports of illness or adverse reactions due to consumption of these products.
Consumption of food contaminated with Listeria monocytogenes can cause listeriosis, a serious infection that primarily affects older adults, persons with weakened immune systems, and pregnant women and their newborns. Less commonly, persons outside these risk groups are affected.
Listeriosis can cause fever, muscle aches, headache, stiff neck, confusion, loss of balance and convulsions sometimes preceded by diarrhea or other gastrointestinal symptoms. An invasive infection spreads beyond the gastrointestinal tract. In pregnant women, the infection can cause miscarriages, stillbirths, premature delivery or life-threatening infection of the newborn. In addition, serious and sometimes fatal infections in older adults and persons with weakened immune systems. Listeriosis is treated with antibiotics. Persons in the higher-risk categories who experience flu-like symptoms within two months after eating contaminated food should seek medical care and tell the health care provider about eating the contaminated food.
FSIS and the company are concerned that some product may be frozen and in consumers' freezers.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
FSIS advises all consumers to reheat ready-to-eat product until steaming hot.
Consumers with questions regarding the recall can contact Barry VanderVeur, Vice President of Operations at (801)-707-6145. Media with questions regarding the recall can contact David Eaheart, Director of Communications and Marketing at (913)-302-9885.
John
-
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.
Spices USA Inc. Issues Alert on Elevated Levels of Lead in Ground Turmeric
For Immediate Release
September 26, 2016
Contact
Consumers
Company Representative
1-800-583-0250
Media
Dana Cho
305-883-9941
Announcement
Hialeah, FL - Spices USA Inc. is recalling 772 bags, 50 pounds each, of TASTY SAWA GROUND TURMERIC, used for furthering manufacturing or repacking, because it contains elevated levels of lead. Consumers are warned not to use the product. Lead can accumulate in the body over time, and too much of it can cause serious and sometimes permanent adverse health consequences.
TASTY SAWA GROUND TURMERIC was distributed in Florida and New York, and in the Dominican Republic, France, Colombia, Jamaica, and Barbados. Spices USA Inc. sells its products to distributors and re-packers, not directly to consumers.
THE PRODUCT WAS PACKED IN 50 LBS YELLOW POLYPROPYLENE BAGS PRINTED WITH THE FOLLOWING INFORMATION:
BRAND TASTY SAWA
SIZE 50 LB BAGS
LOT NUMBER 120674
USE BY 4/2018
COUNTRY OF ORIGIN: INDIA
The recall was initiated after FDA informed us of positive sample results of the product contained elevated levels of lead. Upon making the proper inquiries about the root cause of this problem, our firm believes that the only possible explanation resides directly in the plant in INDIA where the product was packed.
The product was not handled, modified or opened by Spices USA, Inc. before shipping to buyers. No illnesses have been reported to date in connection with this problem. All buyers have been contacted by Spices USA Inc. and advised to either return or destroy the product and to contact their customers with the same instructions if this product was repacked under another label.
Consumers who have purchased the TASTY SAWA GROUND TURMEIC are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company representative at 1-800-583-0250 between the hours of 9 a.m. to 5 p.m. EST.
John
Recall: Ice Cream
in Pinching Pennies
Posted
http://www.fda.gov/Safety/Recalls/ucm524837.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.
Chocolate Shoppe Ice Cream Company Recalls Select Products Containing Chocolate Chip Cookie Dough Pieces Purchased From Outside Supplier Aspen Hills Due To Possible Health Risk
For Immediate Release
October 11, 2016
Contact
Consumers
Customer Service
info@chocolateshoppeicecream.com
1-800-466-8043
Announcement
View Product Photos
http://www.fda.gov/Safety/Recalls/ucm524837.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-photos
Madison, WI - Chocolate Shoppe Ice Cream Company, Inc. is recalling select ice cream products, because they were made with a chocolate chip cookie dough ingredient supplied by Aspen Hills, Inc., which has the potential to be contaminated with Listeria monocytogenes.
Listeria monocytogenes is 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 ice cream products were distributed to the following states AL, AZ, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MI, MN, MO, ND, NE, OH, OK, PA, SC, TX, WA, WI & WV. The ice cream products were distributed to various ice cream shops around the country, online outlets and limited grocery stores.
4,183 3 Gallon Cartons and 5,296 Pints are affected by this recall.
This recall includes the following products with code dates provided:
Chocolate Shoppe Ice Cream Co. 3 Gallon Cartons
Cookie Dough Ice Cream 12/29/17, 12/19/17, 12/13/17, 12/6/17, 11/26/17 & 11/15/17
Heaps of Love Ice Cream 12/29/17, 11/24/17 & 11/8/17
Peanut Butter Cookie Dough 12/1/17 & 11/18/17
Sticks & Stones 12/27/17, 12/2/17 & 11/10/17
Yippee Skippee 12/1/17
Chocolate Shoppe Ice Cream Co. Pints
Cookie Dough Ice Cream 12/13/17, 12/9/17 & 11/26/17
The Baked Bear brand 3 Gallon Cartons
Cookie Dough 12/6/17, 11/26/17 & 11/15/17
The affected product can be identified by the code date listed on the bottom right hand corner of the product label on 3 gallon cartons and by the code date listed on the bottom of each pint.
No illnesses have been reported to date that we are aware of.
Customers are urged to destroy or return the affected products. Full credit will be offered for a full refund of the products in question. Consumers may contact us at 800-466-8043 or via email at info@chocolateshoppeicecream.com.
John