Create a Report
Please provide report title
Please provide location
Please provide details
Get alerts and updates for your case!
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
Add Photo/Video
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 to process your report.


Email us at support@safelyhq.com if you have questions.

Report by
Loading...
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)

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

Goodbye! and best wishes in your recovery

Thumbs Up 7 Male Sexual Supplement - recalled due to undeclared Sildenafil and Tadalafil, USA

2 years ago

United States

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 70K, 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

304


Related Reports

Pyramid Wholesale is issuing a recall of various brands of products sold as dietary supplements for sexual enhancement because they contain undeclared prescription drugs including Sildenafil (Viagra) and/or Tadalafil (Cialis). There have been no reports of injury or illness, to date. They were sold in bulk to... See More other distributors and retailers in California and out of state.

These products have the potential to cause severe adverse health effects due to misuse, overuse, interaction with other medications, underlying health conditions, and overall lack of oversight or consultation with medical professionals.

The products were distributed under 11 different brand names and varied in product form and size. A full list is available in the link below. Consumers should immediately discontinue use of the product.

Company name: Pyramid Wholesale
Brand name: Various
Product recalled: Dietary supplements for sexual enhancement
Reason of the recall: Undeclared Sildenafil and/or Tadalafil
FDA Recall date: March 20, 2024

Source: fda.gov
See Less
288


Several brands of folic acid tablets have been recalled in Canada due to concerns that affected lots may exceed the acceptable intake limit for N-nitroso-folic acid. The recall involves multiple brands distributed across the country.

-Affected products
Brand: Compliments FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG,... See More Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115NHH
Brand: Equate FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115LRJ & 2G3115NHF
Brand: Health One FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115NJL
Brand: Nature's Bounty FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2340T8130A
Brand: Pharmasave FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115NHG
Brand: Sisu FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115M1C

Consumers are advised to consult their healthcare provider if they have any health concerns related to this recall.

Return affected product to your local pharmacy or place of purchase. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.

If you or a loved one are harmed or experiencing any symptoms, it is important to report it. Reporting can help to detect & resolve outbreaks early and prevent others from being harmed, and enables better surveillance. If symptoms persist, seek medical care.

Source: recalls-rappels.canada.ca
See Less
84


Central Valley Ag Cooperative has voluntarily recalled its GS Hamster/Gerbil + Turmeric food due to a potential Salmonella contamination. The recall affects both animals and humans and is currently ongoing. The recalled product has been distributed in Kansas.

The recalled product is GS Hamster/Gerbil + Turmeric, sold... See More in bulk super sacks. A total of 7,464 pounds of the product, bearing the lot number B0624179808 11399 OXBOW and a best before date of 2/6/2026, have been recalled.

The recall was initiated after an ingredient in the gerbil/hamster feed tested positive for Salmonella.

The issue was discovered during routine testing by the company. The recall was initiated on February 26, 2024.

In case you are experiencing Salmonella symptoms such as diarrhea, abdominal cramps, and fever, it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Source: accessdata.fda.gov
See Less


Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), is voluntarily recalling one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product is being recalled due to the potential for the presence of silicone particulates in the product... See More solution. The lot was distributed nationwide to wholesalers and hospitals from June 16, 2022, through October 17, 2022. To date, Par has not received any reports of adverse events related to this recall.

Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs, or brain which can cause stroke and even lead to death.

Treprostinil Injection is formulated for subcutaneous or intravenous infusion. The product is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension to diminish symptoms associated with exercise and for patients who require a transition from epoprostenol to reduce the rate of clinical deterioration.

Treprostinil Injection 20mg/20mL (1mg/mL) is distributed in 20mL multidose vials as sterile solutions in water for injection, individually packaged in cartons under NDC #42023-206-01. Only Lot 57014, expiration date 04/2024 is affected by this recall. Vials from the affected lot bear the attached label.

Par is providing written notification to wholesale accounts and the hospital location that has received the affected lot and is arranging for the return of all existing inventory of Lot 57014 through Inmar, Inc. Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue the use and stop distribution immediately.

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.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Endo International, Par Pharmaceutical
Brand name: Par Pharmaceutical
Product recalled: Treprostinil 20mg/20mL Injection
Reason for the recall: Potential Presence of Silicone Particulate Matter
FDA Recall date: March 12, 2024

Source: fda.gov
See Less
303


Megadyne issued a Class 1 Medical Device Correction to hospitals to limit the use of MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes to patients aged 12 years or older after receiving reports of adult and pediatric patient burns following surgical procedures in which MEGA... See More SOFT pads were used. These reports of patient burn injuries described up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients. Severe burns could lead to potentially long-lasting impacts on patients especially under the age of 12 years.

Since that notification, we have continued to monitor device performance through post market surveillance, investigated every event reported and evaluated potential root cause of these events. Megadyne recently received a report of pediatric use that included a serious 3rd degree patient burn. We are providing this additional broad public communication to increase awareness that MEGADYNE™ MEGA SOFT™ Universal and Universal Plus products should not be used for patients under the age of 12 years.

The list below contains the specific product and codes in scope.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Patient Return Electrode, Product Code: 0845, UDI-DI: 10614559103906.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Dual Patient Return Electrode, Product Code: 0846, UDI-DI: 10614559104248.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Plus Patient Return Electrode, Product Code: 0847, UDI-DI: 10614559104842.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Plus Dual Patient Return Electrode, Product Code: 0848, UDI-DI: 10614559104859.

Customers should review and follow the instructions provided in the December 2023 recall notification (link given below). Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes pads may continue to be used for patients over 12 years of age.

Confirm that personnel using the Mega Soft Universal and Universal Plus pads understand the intended use is changing to patients aged 12 years and older and have stopped using the pads on patients under the age of 12 years. Hospitals using this product should confirm receipt of the recall notification using the business reply form provided with the initial recall notification.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Megadyne Medical Products, Inc.
Brand name: Megadyne
Product recalled: Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes
Reason for the recall: Limit use to patients aged 12 years or older.
FDA Recall date: February 29, 2024

Recall link of December 2023: jnjmedtech.com
Source: fda.gov
See Less
303


Ordered a pillow in November 28 2022. Took my money and never received my product. Now they refuse to answer my p.m or emails. See Less


NV Energy reported a power outage impacting about 2,769 customers in Reno, Washoe County on Wednesday afternoon, Mar 27. The outage was first reported at 2.50 p.m. The estimated time for restoration is not available at this time.The cause of the outage is under investigation.

Outage link:... See More nvenergy.com outages-and-emergencies/view-current-outages' target='_blank' rel='noopener'>nvenergy.com
Source: nvenergy.com
Published: 2024-03-27
See Less
317


According to city officials in Escanaba, a boil water advisory has been issued due to construction. Affected areas include 600, 700, and 800 blocks of 20th Street. 600, 700, 800, 900, 1000, 1100, 1200 blocks of 19th Street. 1,800 and 1,900 blocks of 6th Avenue S. 1,900,... See More 2000, 2,100 blocks of 8th Avenue S. 1,800 blocks of 10th Avenue S, and 1,100 S South Street.

Source: uppermichiganssource.com
Published: 2024-03-27
See Less
8


Recent Interesting Reports

I received a package from 895 MEYERSIDE Dr. in Mississauga. Reference number was 44084898031409****. It was too small earplugs. I didn’t order anything from this address and hopefully there’s nothing on my debit or Visa account. I will be checking this out monthly. See Less
270


Verti, Ohio, USA

1 week ago

I didn’t order this product. It came in the mail and I was charged $55 and $99 to my bank account. See Less
187


I ordered a one time teeth whitening & now I keep Receiving 4 Whitening pens are month that I did not order.

I must have ordered a one time whitening system (I don’t remember doing that) But now I’ve gotten two shipments of 4 each extra whitening... See More pens that I did not order. And there is no phone number or way to reach this company to cancel it. I am 73 years old, and do my best to figure this out, but I cannot afford this. Please help! See Less
1.4K


I received a small package about 5 inches wide, 6 inches long in bubble wrap Envelope with four, inch round Blue aluminum micro thin pieces That I didn’t order I open the container thinking it was something I had ordered previous but it was not. And yes... See More I wonder how this company whatever it is. Got my address. See Less
58


I purchases a cordless lawn trimmer paid 38.90 plus tax was charge to my credit card and never received, Bye a cordless Lawn Trimmer on July 9 2023 and never received and my credit card was charge See Less


When I opened the first lighter, it flickered and then lit. When I tried to operate the other 4 lighters, none of them worked. Went back to the first lighter, and it.would not re-light. Plus the lighter boxes are very hard to open,,one of the box lids tore at the top. What do you suggest? See Less
121


Last 30 days