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IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

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Heart and Soul Cafe, 0 Central St, Ipswich, MA 01938, USA

Total all time reports:  1
Latest report: April 21, 2020 12:00 PM
Restaurant worker test positive for COVID-19, Heart and Soul Cafe, 0 Central St, Ipswich, MA 01938, USA

Restaurant worker test positive for COVID-19

April 21, 2020 12:00 PM

“One worker at Heart and Soul Cafe in Ipswich has tested positive for COVID-19.

Source: thelocalne.ws See Less
Reported By SafelyHQ.com User

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Recent Interesting Reports

July 13, 2020 5:32 AM

“I am so disgusted. Raw chicken 🥴🥴🥴🥴 See Less
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August 5, 2020 9:01 PM

“Company name: Ferring Pharmaceuticals US
Brand name: Ferring, Amring, CSL Behring
Product recalled: DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL
Reason of the recall: Superpotency
FDA Recall date: August 05, 2020
Recall details: ... See MoreFerring Pharmaceuticals US is voluntarily recalling all lots on the market of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE® Nasal Spray 1.5 mg/mL listed in the table below to the consumer level. These products are being recalled due to superpotency or amounts of desmopressin higher than specified. These out of specification results were obtained during routine testing. The risks associated with higher than specified amounts of desmopressin relate to abnormally low levels of sodium in the blood (i.e., hyponatremia) which could eventually lead to seizure, coma, and death.

To date, Ferring has not received an increase in adverse event reports due to increased concentrations of desmopressin from users of the nasal spray. A single non-fatal adverse event potentially associated with this issue was reported in the US during the timeframe that the affected product was distributed. DDAVP® Nasal Spray is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.

Desmopressin Acetate Nasal Spray is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.

Stimate® Nasal Spray is indicated for the treatment of patients with hemophilia A with Factor VIll coagulant activity levels greater than 5%.

Stimate® Nasal Spray is indicated for the treatment of patients with mild to moderate classic von Willebrand’s disease (Type I) with Factor VIII levels greater than 5%.

Ferring US is notifying its distributors and wholesale customers by letter and asking them to check for impacted product and to return unused product through directions provided in the recall letter. You can see the affected product name, including the batch numbers and expiration dates, in the link below.

Distributors/wholesalers with questions regarding the recall should call Stericycle at 1-888-228-5053. 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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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May 15, 2020 11:00 AM

“Company name: Summitt Labs
Brand name: KORE ORGANIC
Product recalled: Watermelon CBD oil tincture
Reason of the recall: Contains lead
FDA Recall date: May 15, 2020
Recall details: Summitt Labs is voluntarily recalling Batch#730 Lot#K018 of KORE ORGANIC Watermelon CBD Oil Tincture, 30 ml bottle ... See More, 15mg 450x to the consumer level. The Florida Department of Agriculture and Consumer Services tested a random sample and found the product to contain lead levels at 4.7 ppm. When informed of this, Summitt Labs issued an immediate voluntary recall and started an internal investigation. As part of this investigation Summitt Labs had a sample from Batch #730 Lot #K018 tested at an ISO/IEC accredited lab. Lead results were 500 ppb (.5ppm), which is within the legal limits as defined by the State of Florida. However, based on the test from the Florida Department of Agriculture and Consumer Services, Summitt Labs initiated, and will complete, a full recall of Batch #730 Lot #K018 in full cooperation with the FDA and Florida Department of Agriculture and Consumer Services.

Summitt Labs is an inspected and licensed facility under the Florida Department of Food and Agriculture and Consumer Services to produce products containing CBD but the Federal Food and Drug Administration does not consider CBD to be a legal drug or dietary supplement. Ingestion of KORE ORGANIC Watermelon CBD Oil Batch #730 Lot #K018 containing lead could result in high lead exposure. According to the Florida Department of Health, acute lead poisoning could have signs and symptoms including but not limited to; Pain, Muscle Weakness, Paresthesia, Abdominal Pain, Nausea, Vomiting, Diarrhea, Constipation, Poor appetite, Weight Loss, Symptoms associated with encephalitis, Metallic taste in the mouth, Shock, Hemolysis, and Kidney Damage. To this date, Summitt Labs has not had a call, complaint or report of any adverse effect from the use of this product.

The product labels states that benefits may include, Anxiety Relief, Pain Reduction, Mood Enhancer, Restful Sleep and may Alleviate Stress. The product is packaged in 30 milliliter bottles; which could come in 9 count displays in Kraft paper packaging. The affected Kore Organic Watermelon CBD Oil lots include Batch#730 Lot#K018. The Product can be identified by the Kore Organic Logo and Kraft Paper Packaging on the 30 milliliter bottle. The product was distributed nationwide by Wholesalers (I.E. Nirvana Kulture and North East Rally), Samples by Sales Personnel, Tradeshow Samples, and by Summitt Labs. Summitt Labs is notifying its distributors and customers by email, phone, and personal visits to ensure the return of all recalled product.

Consumers, distributors and retailers that have Kore Organic Watermelon CBD Oil Batch #730 Batch #K018, which is being recalled, should stop using the product. Any consumer with Lot #K018 Batch #730 should return this product to the place of purchase for a full monetary refund. If that is denied, please contact Summitt Labs at the above number for refund information and any other information regarding this recall.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

July 13, 2020 1:00 PM

“Company name: Ridley Block Operations
Brand name: Ultralyx
Product recalled: 12% Protein Sheep feed
Reason of the recall: Elevated levels of copper
FDA Recall date: July 13, 2020
Recall details: No other products are affected Ridley Block Operations is voluntarily recalling Ultralyx® 12% Protei ... See Moren Sheep with batch number HB01679401. The product has been found to contain elevated levels of copper. With prolonged consumption, the affected product could potentially have adverse health effects on sheep, including reductions in daily gains, icterus, partially cirrhotic livers and hemoglobin-stained kidneys. Occasionally, death occurs in copper-toxic sheep.

This recall relates only to Ultralyx 12% Protein Sheep with the following batch numbers printed on the package:

- Product Name: Ultralyx 12% Protein Sheep
- Batch/Lot# : HB01679401
- Item No./Product No.: 24419
- Package Info.: 50# Block

Customers are asked to remove all product matching this batch number from distribution and inventory and discontinue feeding it immediately.

No other batch number or other Ridley Block Operations products are involved in this voluntary recall. Of the batch of twenty blocks included in the recall, two blocks remain in the marketplace.

Ridley Block Operations will continue to work closely with the Food and Drug Administration throughout the recall process. Our representatives are in direct communication with our customers to ensure the proper identification and removal of the impacted products.

Check the full recall details on fda.gov

Source: FDA
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June 27, 2020 10:00 AM

“Company name: Saniderm Products
Brand name: Saniderm
Product recalled: Advanced Hand Sanitizer
Reason of the recall: May contain methanol (wood alcohol)
FDA Recall date: June 27, 2020
Recall details: Saniderm Products (Saniderm) is voluntarily recalling Saniderm Advanced Hand Sanitizer, packag ... See Moreed in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). To date, Saniderm has not received any reports of adverse events related to the product in question.

In response to a recent news alert by the Food and Drug Administration advising consumers of potentially toxic hand sanitizer manufactured by Eskbiochem SA de CV in Mexico, Saniderm has proactively taken necessary precautions to ensure the safety of consumers. Out of an abundance of caution, Saniderm has initiated a voluntary recall of all products produced by Eskbiochem SA de CV with a “Made in Mexico” origin.

The product is a hand sanitizer and is packaged in 1-liter plastic bottles with an orange twist-top cap. The affected Sandiderm Advanced Hand Sanitizer include lot number 53131626, manufactured date April/1/20, clear bottle that can be further distinguished by looking at the back side label and identifying “Made in Mexico” and “Produced by: Eskbiochem SA de CV”. No other bottles distributed by Saniderm match the description above, hence all products as described above are subject to the voluntary recall. The product can be identified by the photos below. The product was distributed in Virginia, Maryland, and New Jersey on April 15,2020.

Risk Statement: Substantial methanol exposure “could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.”

Saniderm is notifying its distributors and customers by email and is arranging for the handling of all voluntary recalled products. All individuals that have the bottle in question should immediately stop using and contact Saniderm for guidance on the return and disposal of the product. Consumers with questions regarding this voluntary recall can contact Saniderm at +1 (415) 562-5502‬ or info@sanidermproducts.com from Monday-Friday 9am-6pm, PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product. 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

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

March 17, 2020 8:43 PM

“Interview - Maroy, Lyon France:
This is a first hand account of the coronavirus situation in Lyon France, including one member of their community that has been diagnosed, and another working in a nearby hospital.

Maroy:
I am 25 and I'm living in Lyon in the east France and it's like the third ... See Moreregion which is the most touched by the virus. And right now I'm at home since Monday the government told us to stay at home, so I'm not touched by the virus, but I know some, an old person who are touched by the virus. And I have a friend who is working in the hospital in the care units and she explained to me what the media is hiding and what's the truth behind this virus.

Safelyhq:
What area does your friend work in the hospital? And what is she seeing?

Maroy:
She's living in the South of France, Toulouse and she's in the care units. So she's working closely with the people who are in the worst situation in the hospital. So she see's a lot of cases everyday and everyday she's told me that it's worse.

Safelyhq:
Some of the materials state that it's mostly older people that are impacted, is that what she's seeing?

Maroy:
So at first in the media, they say that only old people and fragile persons who have a disease are impacted. But now this is not the truth. Now,people who are 23 years old, 25, 30 are impacted.

Safelyhq:
Have you heard anything about testing? Is it hard to get testing or is it easy to get testing?

Maroy:
Yes. One week ago I was talking with my doctor and we were talking about the virus and he told me, you know, we are talking a lot with the other doctors and I can tell you right now that we don't have in France,no testing, no tests anymore. We don't know if a person has a flu, if it's simple flu or the coronavirus and when he told me that I was really anxious because even the doctors can't diagnose now if this only a flu or if it's worse.

Safelyhq:
At the hospital, where your friend works? Is there enough room for people or are they worried about how much space they have?

Maroy:
No, unfortunately not. Now they are transferring patients to another hospital to welcome the patients who are infected by the virus. And I also heard that in some hospitals they are taking the children's room. So the services reserved for children, they are transferred to the care unit because they do not have enough room for them. They don't have enough places now.

Safelyhq:
Is there anyone that you know of or any people that you are aware ofthat directly, or through friends or family that have been diagnosed with coronavirus?

Maroy:
Yes, the cousin of my husband has been diagnosed so she's at home. She can't be at the hospital because there are too many people and they said that if she don't have struggle to breathe, she needs to stay at home. The government said that you can call emergency, only if you're struggling to breathe, if you should just have fever. Or a cough if you cough you stay at home, but really if you can't breathe you can call the emergency.

Safelyhq:
So now that you've had experience in France with coronavirus, and hearing about your husband's cousin and your friend at the hospital, what's your feeling about coronavirus and how serious it is? Are you concerned now that you have had direct impact?

Maroy:
Yes. I'm really mad get the government because they they take that too easily. They didn't do the right things at the beginning. People need to understand that this is really, really serious. And I'm pretty anxious because now yesterday I was doing shopping, so just to buy food and the all people in the grocery was afraid was wearing masks and there was nothing, people were struggling to find some pasta or something like that. And I'm really mad because we can see that a lot and a lot of people are infected by the virus. My friend who is nurse, is really afraid, she's really anxious, she's really scared to have it. She's pregnant and she needs to work even if she's pregnant. And I'm really mad against the government for that. I'm sure that if it took the good decision at the right time, they would not have a lot of cases like right now.

Safelyhq:
Is there any message that you have for people listening based on what you've learnt so far?

Maroy:
Don't take that too lightly. This is really my word, don't take that too lightly. When I see that in UK, they say that they are counting on the auto immunity of people. I just don't understand. If I have a thing to say it, don't shake hands, don't hug someone, wash your hands carefully, and just take it this really, really seriously. Because this is not a simple flu. It's bigger than that.
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Reported By SafelyHQ.com User

July 6, 2020 12:53 PM

“Order from Walmart delivers. SOUTHERN HENS (frozen chicken.)
When thawed and removing giblets, to my horror, there was a brow ... See Morele="Product: Egg">egg inside the hen!!!! The inside of the egg had dispersed but the shell was partly attached to itself. Contacted company and they told me that they had never heard of anything like this before... I have pics!!!!! Reported to Walmart and they are STILL SELLING THEM!!!!!
I would also like to name all the agencies in MS That I contacted and they kept telling me they were not responsible?!? Six Mississippi agencies where this plant is located...Yet Walmart keeps selling them!!
I called the Board of Health in Mississippi, I called the FDA, the USDA, I called Southern Hen and spoke to a person. There was no action taken, none! nobody cares that there was a frickin egg inside of a frozen hen See Less
Reported By SafelyHQ.com User

June 23, 2020 8:01 PM

“Company name: Golden Nutrition Inc.
Brand name: Golden Nutrition Inc.
Product recalled: Anti-Viral Immune Enhancement Capsules
Reason of the recall: Unsubstantiated Health Claims on Label
FDA Recall date: June 23, 2020
Recall details: Golden Nutrition Inc. of Opa Locka, Florida is recalling fou ... See Morer (4) Lots of Anti-Viral Immune Enhancement Capsules because the label makes unsubstantiated health claims. The recalled Anti-Viral Immune Enhancement were distributed to distributors through orders. The distribution is in Puerto Rico where consumers are able to get the product via retailers.

The product of 60 capsules comes in a green 150cc PET Bottle, with a gold cap marked with lot and expiration number on the bottom of the bottle. The Lot and expiration numbers that are being recalled are the following: Lot:1493 with Expiration: 04/2023, Lot:1499 with Expiration: 04/2023, Lot:1513 with Expiration:05/2023, and Lot:1515 with Expiration 05/2023.  

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

The noncompliance with FDA regulations for label claims was noted after one of our distributors brought it to our attention. The label makes unsubstantiated health claims that the product “helps fight corona virus and influenza.” Consumers that use this product instead of seeking medical treatment run the risk of serious, life threatening health consequences. The production of the product has been suspended while the company works to correct the label. Consumers who have purchased the Anti-Viral Immune Enhancement are urged to return them to the place of purchase for a full refund.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

July 13, 2020 4:00 PM

“Company name: 4e Brands North America
Brand name: Blumen
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared Methanol
FDA Recall date: July 13, 2020
Recall details: Company Announcement San Antonio, Texas, 4e Brands North America is voluntarily recalling ten (10) bottle sizes of H ... See Moreand Sanitizers to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. To date, 4e Brands North America has not received reports of adverse events related to this recall. Recalled Products These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. The affected Hand Sanitizers are packaged in clear plastic bottles. The recalled products are as follows (a full listing of lot numbers in numerical order is included below the chart):
Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User