Create a Report
Please provide report title
Please provide location
Please provide details
Get alerts and updates for your case! Your contact information is not shown on the website.
This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.
Please provide email or phone
Please provide email or phone

We do not show your email or contact info

Please accept our Terms & Conditions
Add photos or video
We recommend photos and videos to help explain your report
Use camera
Select from library
Email or SMS copy of report
Enter below to get emailed a copy of your report, or sms a link to your report
Please provide email or phone
Please provide email or phone
Please accept our Terms & Conditions
Thank you for your report!
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)
Visit our learn pages for more helpful information or, email us: support@safelyhq.com
Goodbye! and best wishes in your recovery
Report by
Please provide location
Please provide location
Please provide report title
Please provide details
Please accept our Terms & Conditions
Get alerts and updates for your case! Your contact information is not shown on the website.

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

or
Please provide email or phone
Thank you for your report!

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)

If your report is poison related call 1-800-222-1222 for a free consultation with a live medical poisoning expert

Visit our learn pages for more helpful information or, email us: support@safelyhq.com

Goodbye! and best wishes in your recovery

Vermont, United States

Updated: April 7, 2021 12:00 PM

Covid-19 OSHA Complaint, Water Wheel Trading Post, LLC, 4900 U.S. 4, KILLINGTON, VT, 05751, USA

Water Wheel Trading Post, LLC, 4900 U.S. 4, KILLINGTON, VT, 05751, USA

April 7, 2021 12:00 PM

“Alleged that employees are not wearing masks. Location: Entrance of store


Source: Osha.gov | Receipt Date: 2021-03-08 See Less
Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, US Postal Service, 95 Sykes Mountain Dr., WHITE RIVER JUNCTION, VT, 05001, USA

US Postal Service, 95 Sykes Mountain Dr., WHITE RIVER JUNCTION, VT, 05001, USA

April 7, 2021 12:00 PM

“1. Employees are not being properly trained on the machinery they are operating, exposing them to crushing and caught in hazards. 2. Employer is not following OSHA guidance to protect workers from exposure to Covid-19: Employer did not adapt infection control strategies based on a thorough hazard as... See Moresessment, using appropriate combinations of engineering and administrative controls, safe work practices, and taking appropriate steps to protect other workers from exposure to SARS-CoV-2, the virus that causes COVID-19, in the workplace. These steps might include mandatory mask use, physical distancing or actions as a result of a confirmed case, such as cleaning and disinfecting the work environment, notifying other workers to monitor themselves for signs/symptoms of COVID-19, following quarantine guidelines or implementing a screening program in the workplace (e.g., for signs/symptoms of COVID-19 among workers).

Alleged Hazards: 2, Employees Exposed: 25
Source: Osha.gov | Receipt Date: 2021-03-15
See Less
Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, OLD NAVY, LLC, 100 Maple Tree Place, WILLISTON, VT, 05495, USA

OLD NAVY, LLC, 100 Maple Tree Place, WILLISTON, VT, 05495, USA

March 31, 2021 12:00 PM

“Hazard Description: Employee concerns over Assistant Manager visiting Lake Placid, NY on weekends and returning to Vermont and work the following Monday without quarantining. Location: Store in Williston, VT


Source: Osha.gov | Receipt Date: 2021-03-10 See Less
Reported By SafelyHQ.com User
Vaccine Side Effects Special summary

Covid-19 OSHA Complaint, OLEO CORPORATION, 2940 Vermont 103, CAVENDISH, VT, 05142, USA

OLEO CORPORATION, 2940 Vermont 103, CAVENDISH, VT, 05142, USA

March 31, 2021 12:00 PM

“Hazard Description: Employee's spouse alleges employee has tested positive and employer is not following proper protocols for quarantining, contact tracing, and disinfecting the area in which the positive employee had worked. Location: Front desk/Business Area


Source: Osha.gov | Receipt Date: 202... See More1-03-05 See Less
Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, MIDSTATE AUTO GROUP OF VERMONT LLC, 1365 US Route 302, BARRE, VT, 05641, USA

MIDSTATE AUTO GROUP OF VERMONT LLC, 1365 US Route 302, BARRE, VT, 05641, USA

March 31, 2021 12:00 PM

“The owner traveled out of the state of VT. Upon return the owner came back to work the next day. The owner did not quarantine and did not get tested for COVID19.


Source: Osha.gov | Receipt Date: 2021-03-05 See Less
Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Naylor & Breen Builders, Inc., 55 Torrey Knoll, Manchester Center, VT 05255, USA

Naylor & Breen Builders, Inc., 55 Torrey Knoll, Manchester Center, VT 05255, USA

March 31, 2021 12:00 PM

“Hazard Description: Alleged that employees are not required to wear masks when in the presence of others to include while car pooling, eating lunch, and completing tasks at worksite. Alleged that lifts at site are unsafe and harnesses are not required when employees utilize them. Alleged that employ... See Moreer expects employees to work on roofs without fall protection and required/appropriate fall protection is not discussed prior to each roofing job. Alleged that employer recently conducted inadequate fall protection training because the person conducting the training was not a Competent Person. Alleged that employer does not provide personal protective equipment and expects employees to work with fiberglass without protective gear. Alleged that employer does not have a respiratory protection program. Alleged that employer has employees cutting hardy board without respiratory protection or vacuum integration system. Location: Worksite located off Richville Road in Manchester, VT, near downtown.

Alleged Hazards: 9, Employees Exposed: 2
Source: Osha.gov | Receipt Date: 2021-02-16
See Less
Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, O'REILLY AUTO ENTERPRISES, LLC, 56 Vt Route 15 West, MORRISTOWN, VT, 05661, USA

O'REILLY AUTO ENTERPRISES, LLC, 56 Vt Route 15 West, MORRISTOWN, VT, 05661, USA

March 31, 2021 12:00 PM

“Employer not screening employees. Employer not sending symptomatic employees home. Employer not enforcing mask wearing/social distancing amongst employees. Employer not requiring customers to wear masks.


Source: Osha.gov | Receipt Date: 2021-01-13 See Less
Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Inner Fire, 26 Parker Road, BROOKLINE, VT, 05345, USA

Inner Fire, 26 Parker Road, BROOKLINE, VT, 05345, USA

March 31, 2021 12:00 PM

“Employers are encourages to return to work while showing symptoms of illness.


Source: Osha.gov | Receipt Date: 2020-12-28 See Less
Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Vermont Department of Corrections, 1270 US Rt 5, SAINT JOHNSBURY, VT, 05819, USA

Vermont Department of Corrections, 1270 US Rt 5, SAINT JOHNSBURY, VT, 05819, USA

March 24, 2021 12:00 PM

“Alleged that the Department of Corrections COVID-19 policy is not consistent with the Department of Health protocols for infection control practices. Location: Entire Northeast Correctional complex.


Source: Osha.gov | Receipt Date: 2021-02-23 See Less
Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, WHITE RIVER MOTORS, INC., 303 SYKES MOUNTAIN AVE, WHITE RIVER JUNCTION, VT, 05001, USA

WHITE RIVER MOTORS, INC., 303 SYKES MOUNTAIN AVE, WHITE RIVER JUNCTION, VT, 05001, USA

March 24, 2021 12:00 PM

“White River Toyota entire building: Alleged improper quarantining of alleged COVID infected employees. Alleged employees travelling out of state did not quarantine on return. Alleged non-public facing employees improperly or not wearing face masks.


Source: Osha.gov | Receipt Date: 2021-02-22 See Less
Reported By SafelyHQ.com User

Recent Interesting Reports

J&J vaccine, Raleigh, NC, USA

Symptoms: Fever Itching
Raleigh, NC, USA

March 29, 2021 9:50 PM

“My wife and I wanted to get the CoV2 vaccine but had significant concerns about the messenger RNA versions.
Anyway, we got the J&J vaccine, and we are satisfied with it.

However, some things need to be stated. My wife had a 103.3-degree fever the night of her shot. I didn't feel great, but the... See Moreaftereffects took longer to present themselves. While I had a slight fever, my response presented itself as bruises that itched terribly.

We are two weeks out from the vaccine, and things are going back to normal. My wife and I had to build up our stamina from the day of the shot and now (two weeks and four days ago).

Overall, we still feel that the J&J jab was the best vaccine for us. Even though this vaccine's efficacy looks less than the others, it is quite comparable if you look at the places it was tested and when it was tested.

We would highly recommend this vaccine to all who would prefer a more conventional vaccine.
See Less
Reported By SafelyHQ.com User

March 31, 2021 10:00 AM

“Company name: Ummzy LLC
Brand name: Thumbs Up 7, Shogun, Krazy Night
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil, Tadalafil, Vardenafil
FDA Recall date: March 31, 2021
Recall details: Palisades Park, NJ, Ummzy LLC is voluntarily r... See Moreecalling all lots of Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night capsules to consumer level. FDA analysis has found the product to contain undeclared tadalafil sildenafil & Vardenafil. Tadalafil, Sildenafil & Vardenafil are ingredients known as phosphodiesterase (PD-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The presence of Tadalafil Sldenafil & Vardenafilin Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night capsules makes them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.

Consumers with underlying medical issues who take Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night capsules with undeclared Tadalafil Sildenafil & Vardenafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening.

Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Ummzy LLChas not received any reports of adverse events related to this recall. This tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in blister foil sheets in a box containing 10 capsules. The affected lot numbers of Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night includes all lots. Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night was distributed nationwide in the USA via internet and fulfilled by amazon at www.amazon.com.

On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms. Ummzy LLC is notifying its customers by this press announcement and via e-mail of this recall.

Consumers that have Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night, which is being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact Ummzy LLC by phone at 201-416-9325 Monday to Friday from 9AM to 5PM or e-mail ysknabe75@gmail.com. For more information, please visit www.ummzyllc.com.

Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or 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. 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
See Less
Reported By SafelyHQ.com User

March 16, 2021 5:00 PM

“Company name: Bravo Packing, Inc.
Brand name: Bravo Packing, Inc.
Product recalled: Pet food: Performance Dog, beef, green tripe, and bone
Reason of the recall: Due to Potential Salmonella and Listeria monocytogenes
FDA Recall date: March 16, 2021
Recall details: Bravo Packing, Inc. of Carneys... See MorePoint, NJ is expanding the previously announced voluntary recall of two pet food products to now include all pet food and bones in all package sizes. During an FDA inspection, samples collected tested positive for Salmonella and Listeria monocytogenes and resulted in a recall due to the potential health risks to humans and pets.  Bravo Packing, Inc. is expanding the recall due to potential cross contamination.

No human or animal illnesses related to the identified products have been reported to date. Bravo Packing Inc. generally works with distributors that fill orders to retail stores and to consumers directly nationwide. Consumers with any of the affected products should handle them with caution, discard products in a secure container, and wash hands and surfaces properly. Consumers with questions should contact Bravo Packing, Inc. at 856-299-1044 (Monday – Friday, 9:00 AM-2:00 PM, EST). Recalled Products:

- “Performance Dog” (chub) frozen raw dog food (2 lbs.)
- “Performance Dog” (chub) frozen raw dog food (5 lbs.)
- “Green Tripe” (chub - ground bovine stomach) frozen raw dog food (2 lbs.)
- “Green Tripe” (chub - ground bovine stomach) frozen raw dog food (5 lbs.)
- “Beef” (chub - ground) frozen raw dog food (2 lbs.)
- “Beef” (chub - ground)frozen raw dog food (5 lbs.)
- “Performance Dog” (patties) frozen raw dog food (unknown)
- “Tripe” (patties ¼ lbs.) frozen raw dog food (unknown)
- Bones (smoked) 14 varieties (unknown)

Salmonella can cause illness in pets eating the products, as well as people who handle contaminated pet food products, especially if they have not thoroughly washed their hands after having contact with the products, infected pets, or any surfaces exposed to these products. People infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping, and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis (an infection of the heart muscle), arthritis, muscle pain, eye irritation, and urinary tract symptoms. People who have these symptoms after having contact with the products identified in this recall or with a pet that has eaten these products should contact their healthcare providers.

A pet with a Salmonella infection may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have decreased appetite, fever, and abdominal pain. If your pet has consumed the recalled products and has these symptoms, please contact your veterinarian. Pets exposed to contaminated food can be infected without showing symptoms. Infected pets, including those without symptoms, can also shed Salmonella through their feces and saliva, spreading pathogens into the home environment and to humans and other animals nearby.

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 monocytogenes infection can cause miscarriages and stillbirths among pregnant women.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User
Vaccine Side Effects Special summary

I am reporting Pfizer vaccine, Lecompte, LA 71346, USA

Symptoms: Other Headache
Lecompte, LA 71346, USA

March 22, 2021 7:48 PM

“In February I received my 1st dose of Pfizer vaccine and I did get a headache.. yet it was the second dose on March 3 that made me go to the doctor and found that that vaccine has cause me to have high high blood pressure! My numbers doubled and I have not recovered. Now on high blood pressure me... See Moreds. The doctor says I have fluid built up around my heart and palpitations that are driving me to unhappy days.
Letting you know. .
See Less
Reported By SafelyHQ.com User

March 24, 2021 9:25 AM

“My yar old cocker spaniel just had a seizure  after giving him 2 dream bone peanut butter treats! Poor lil guy ate 2 of these shitty made in China peanut butter treats! Next thing I see is him convulsing on the floor uncontrollably! Very sad to have to watch! His half sister has been having them for... See More2 years , but it’s gotta be coming from this treat. Do not ever feed your dogs these. I am devasted to now have 2 dogs that have has seizures due to this. See Less
Reported By SafelyHQ.com User

March 29, 2021 8:00 PM

“Company name: Antoto-K
Brand name: Thumbs Up 7
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and Tadalafil
FDA Recall date: March 29, 2021
Recall details: Manassas, VA, Antoto-K is voluntarily recalling all lots of Thumbs Up 7 Red 7... See More0K, 10 capsules to consumer level. FDA analysis has found the product to contain undeclared Sildenafil and Tadalafil. Sildenafil and Tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction.

The presence of Sildenafil and Tadalafil in Thumbs Up 7 Red 70K, 10 capsules makes them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall. Consumers with underlying medical issues who take Thumbs Up 7 Red 70K, 10 capsules with undeclared Sildenafil and Tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

To date, Antoto-K has not received any reports of adverse events related to this recall. This tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in foil sheet and a box containing 10 capsules. The affected lot numbers of Thumbs Up 7 Red 70K includes all lots. Thumbs Up 7 Red 70K was distributed via internet and fulfilled by amazon at www.amazon.com nationwide in the USA.

On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms. Antoto-K is notifying its customers by this press announcement and via e-mail of this recall. Consumers that have Thumbs Up 7 Red 70K which is being recalled should stop using and destroy them.

Consumers with questions regarding this recall can contact Antoto-K by email at ngtbtr.k17@gmail.com. Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or 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. 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
See Less
Reported By SafelyHQ.com User

April 6, 2021 5:00 PM

“Company name: Yolo Studio
Brand name: PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Tadalafil
FDA Recall date: April 06, 2021
Recall details: Company Announcement Cli... See Moreffside Park, NJ, Yolo Studio is voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil. Tadalafil is ingredient known as a phosphodiesterase (PDE-5) inhibitor found in FDA approved products for the treatment of male erectile dysfunction. The presence of tadalafil in PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 makes these unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.

Consumers with underlying medical issues who take PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 with undeclared tadalafil may experience serious health risks. For example, PDE- 5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Yolo Studio has not received any reports of adverse events related to this recall. These tainted products are marketed as dietary supplements for male sexual enhancement and are packaged in cardboard blisters containing one pill per card.

The affected lot numbers of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 include all lots. PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 were distributed via internet and fulfilled by amazon at www.amazon.com nationwide in the USA. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.

Yolo Studio is notifying its customers by this press announcement and via e-mail of this recall. Consumers that have PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 which are being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact Yolo Studio by phone at (201) 233-3521 Monday through Friday from 9am to 5pm eastern time zone or e-mail yolostudiodamazon@gmail.com.

Consumers should contact their physicians 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.
- Regular Mail or Fax: 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
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
See Less
Reported By SafelyHQ.com User

March 24, 2021 4:00 PM

“Company name: Alembic Pharmaceuticals, Inc.
Brand name: Alembic
Product recalled: Telmisartan Tablets, USP, 20 mg
Reason of the recall: Incorrect Product Strength on Label
FDA Recall date: March 24, 2021
Recall details: Bridgewater, NJ, Alembic Pharmaceuticals, Inc is voluntarily recalling on... See Moree lot of Telmisartan Tablets, USP, 20 mg, packaged in 30-count bottles, Lot No. 1905005661 to the consumer level. The product is being recalled due to a market complaint received which stated that one bottle labelled as 30-count Telmisartan Tablets, USP, 20 mg incorrectly contained 30 tablets of Telmisartan Tablets, USP, 40mg.

Risk Statement: Patients who could be on a doubled dose of telmisartan for a prolonged period of time, could experience low blood pressure, worsening of kidney function, or an elevation of potassium which can be life-threatening. To date, Alembic Pharmaceuticals Limited has not received any reports of adverse events related to this recall. The product is used for the treatment of hypertension i.e. to lower blood pressure and is packaged in a bottle of 30 tablets having NDC Number 62332-087-30.

The affected lot of Telmisartan Tablets, USP, 20 mg is the lot number 1905005661 and the lot expires in March 2022. The wrong product can be identified by checking the shape and embossing details on the tablets i.e. Telmisartan Tablets, USP, 20 mg bottles may incorrectly contain oval shaped White to off-white tablets debossed with L203 on one side instead of correct product i.e. round shaped White to off-white tablets debossed with L 202 on one side. Telmisartan Tablets, USP, 20mg, Lot No. 1905005661 was distributed Nationwide in the USA to wholesalers, retailers, and pharmacies.

Alembic Pharmaceuticals Limited is notifying its distributors and retailers through letter and is arranging for return of the recalled lot. Consumers that may have Telmisartan Tablets, USP, 20 mg which is being recalled should not discontinue use until speaking with their pharmacist or healthcare professional for a replacement before returning to place of purchase. Consumers with questions regarding this recall can contact Alembic Pharmaceuticals Inc by phone at +1 908-552-5839 (9:00 am – 5:00 pm, EDT, Monday through Friday) or email address david.cobb@alembicusa.com.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

March 31, 2021 12:02 PM

“Company name: Nuri Trading LLC
Brand name: Thumbs Up 7, Shogun-X, 69MODE
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil, Tadalafil, Vardenafil
FDA Recall date: March 31, 2021
Recall details: Nuri Trading is voluntarily recalling all... See Morelots within expiry of Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, and 69MODE Blue 69 capsules to the consumer level. FDA analyses have found these products to contain undeclared tadalafil, sildenafil, and/or vardenafil. Sildenafil,tadalafil, and vardenafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction.

The presence of sildenafil, tadalafil, and/ or vardenafil in Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, and 69MODE Blue 69 capsules make them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.

Consumers with underlying medical issues who take Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, 69MODE Blue 69 capsules with undeclared sildenafil,tadalafil, and/or vardenafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

To date, Nuri Trading has not received any reports of adverse events related to this recall. These tainted products are marketed as dietary supplements for male sexual enhancement and are packaged in blister foil sheets in a box. Each box contains 10 capsules. These products were distributed via internet and fulfilled by amazon at www.amazon.com nationwide in the USA. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.

Nuri Trading LLC is notifying its customers by this press announcement and via email of this recall. Consumers that have Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, 69MODE Blue 69, which are being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact Nuri Trading by phone at (201) 380-1046 Monday to Friday from 9AM to 5PM eastern time or e-mail nuritrading17@gmail.com. For more information, please visit www.nuritradingusa.com.

Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to takin or 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. 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
See Less
Reported By SafelyHQ.com User

March 30, 2021 10:00 AM

“Company name: Bit & Bet LLC
Brand name: Thumbs Up 7
Product recalled: Blue 69K Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and Tadalafil
FDA Recall date: March 30, 2021
Recall details: Bit & Bet LLC is voluntarily recalling all lots of Thumbs Up 7... See MoreBlue 69K capsules to consumer level. FDA analysis has found the product to contain undeclared sildenafil and tadalafil. Sildenafil and tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction.

The presence of sildenafil and tadalafil in Thumbs Up 7 Blue 69K capsules make them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall. Consumers with underlying medical issues who take Thumbs Up 7 Blue 69K capsules with undeclared sildenafil and tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

To date, Bit & Bet has not received any reports of adverse events related to this recall. To date, Bit & Bet has not received any reports of adverse events related to this recall This tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in blister foil sheets in a box labeled with UPC 6 17135 89467 3. Each box contains 10 capsules. The affected lot numbers of Thumbs Up 7 Blue 69K includes all lots. Thumbs Up 7 Blue 69K was distributed via internet and fulfilled by amazon at www.amazon.com nationwide in the USA.

On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, e Bay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms. Bit & Bet LLC is notifying its customers by this press announcement and via email of this recall. Consumers that have Thumbs up 7 Blue 69K, which is being recalled should stop using and descard them.

Consumers with questions regarding this recall can contact Bit & Bet LLC by phone at (201) 208-2836 Monday to Friday from 9AM to 5PM or e-mail thumbsup7blue@gmail.com. For more information, please visit www.thumbsup7blue.com. Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to takin or 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. 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
See Less
Reported By SafelyHQ.com User