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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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Other

Updated: April 4, 2021 6:56 PM

April 4, 2021 6:56 PM

“The CDC announced that they are currently investigating a multistate outbreak of Salmonella infections where 19 people have been reported sick from 8 states (CA, KY, MS, NH, OK, OR, TN, WA). Eight people of the total have required hospitalization but no deaths have been reported to date.

Accordin... See Moreg to the outbreak notice, there are reports of wild songbirds, such as pine siskins (small, streaked, yellow-tinged songbirds in the finch family) sick with the same strain of Salmonella that is making people sick in this outbreak. Salmonella germs can spread between species of birds, to pets, and to people.

You can get sick when you touch your mouth with unwashed hands after touching wild birds, bird feeders or bird baths, or your pets that have contact with wild birds.

CDC advises to:
- Clean and disinfect your bird feeder and bird bath weekly or when they are visibly dirty.
- Do not touch or hand-feed wild birds with your bare hands.
- Always wash your hands with soap and water
- Call your healthcare provider right away if you have any of these severe Salmonella symptoms

Most people infected with Salmonella develop diarrhea, fever, and stomach cramps 6 hours to 6 days after being exposed to the bacteria and the illness usually lasts 4 to 7 days, and many recover without treatment.

Check the CDC website for the full investigation details cdc.gov

Source: CDC
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Reported By SafelyHQ.com User
Doctor Visit: Yes
Diagnosis: Salmonella

March 24, 2021 6:00 PM

“A child was injured by an aggressive dog on the premises. The dog is owned by the owner.  A child was injured by a dog.  See Less
Reported By SafelyHQ.com User

Contaminated milk, Braum's Ice Cream & Burger Restaurant, East 71st Street, Tulsa, OK, USA

Braum's Ice Cream & Burger Restaurant, East 71st Street, Tulsa, OK, USA

March 11, 2021 7:40 AM

“I bought a 1/2 gallon %2 milk a week ago, last night I was going to consume some that I noticed some unusual deposit built up in side in several locations and that brought my attention to several rings of deposits that indicated the amount I used every time. See Less
Reported By SafelyHQ.com User
Vaccine Side Effects Special summary

1st dose Phizer, Albuquerque, NM, USA

Symptoms: Fever Weakness Fatigue Joint Pain Muscle Pain Soreness
Albuquerque, NM, USA

February 27, 2021 11:44 AM

“I got 1st dose of Phizer. After two hours injection site pain left arm, shoulder, neck pain. Joint pain, malaise, fever, weakness, fatigue, muscle pain. After I took Tylenol later in evening felt better. Next morning, feel much better, injection site pain, little joint pain. See Less
Reported By SafelyHQ.com User

Cat food cans had been expired, SuperFresh Glen Rock, Lincoln Avenue, Glen Rock, NJ, USA

SuperFresh Glen Rock, Lincoln Avenue, Glen Rock, NJ, USA

January 3, 2021 5:22 AM

“I bought 9lives canned cat food and 3 of 4 cans had been expired from 11/11/19. Their store is not offering refunds but if I had not looked at the date my cats would have got sick See Less
Reported By SafelyHQ.com User

Employees not wearing masks, Discount Tire, South Market Street, Gilbert, AZ, USA

Discount Tire, South Market Street, Gilbert, AZ, USA

December 22, 2020 6:01 PM

“Employees not wearing masks. Went to get free tire check and had to tell the guy to put his mask on/pull his gator up before I rolled down my window See Less
Reported By SafelyHQ.com User

December 4, 2020 8:45 AM

“I bought two packs of half a kilo of oats in YA brand flakes and both were uncomble, with a lot of taste of dishwashing soap. I had to dounce them practically whole after testing them, the company was communicated but obviously I haven't received any response from you. See Less
Reported By SafelyHQ.com User

December 4, 2020 7:12 AM

“Taste like metal. I called Ore Ida and gave them the bar code and everything was taken care of. The expiration date was good, not the store's fault See Less
Reported By SafelyHQ.com User

Covid-19 Violations, The Iron Waffle Coffee Company, 8785 Interlachen Rd, Nisswa, MN 56468, USA

The Iron Waffle Coffee Company, 8785 Interlachen Rd, Nisswa, MN 56468, USA

November 24, 2020 9:43 AM

“This establishment, after re-opening, has remained openly defiant about mask mandates as well as the latest restriction which prohibits in-person dining. They have been nasty toward anyone expressing concern on their FaceBook page, and even bragging about how "business is booming" since anti-masker... See Mores come to support them in their so-called "fight" for "freedom over fear." See Less
Reported By SafelyHQ.com User

Recent Interesting Reports

Johnson and Johnson Vaccine Review, Perth Amboy, NJ, USA

Symptoms: Soreness
Perth Amboy, NJ, USA

April 6, 2021 10:19 PM

“Got the JnJ vaccine Monday morning 4/5/21 at Wegman’s Bridgewater. Other than my arm being a little sore I have no side effects at all. No head aches, no fevers, nothing! SIDE NOTE: I took a COVID test a few days before to confirm I was COVID free before getting vaccinated. I was on Claritin from th... See Moree night before because allergy season has officially started. I didn’t want the Moderna or Pfizer... not a fan of the lipid MRNA. - Stay Safe guys! See Less
Reported By SafelyHQ.com User

March 25, 2021 9:01 AM

“Company name: Sanit Technologies LLC d/b/a Durisan
Brand name: Durisan
Product recalled: Antimicrobial Hand Sanitizer
Reason of the recall: Due to microbial contamination
FDA Recall date: March 24, 2021
Recall details: Sanit Technologies LLC d/b/a Durisan announces a voluntary recall of the lot... See Mores listed in the table below of Durisan Antimicrobial Hand Sanitizer, Non-Alcohol products in various sizes listed. The products are being recalled due to microbial contamination. Specifically, out of specification results for bacterial count for Burkholderia cepacia complex and Ralstonia pickettii. The issue was discovered during a routine audit focused on production scale-up during the height of the pandemic.

Check the link below for the full list of Durisan Antimicrobial Solutions Hand Sanitizer Sizes and Lot Numbers. To date, no reports of adverse reactions or customer complaints have been reported related to this recall.

The product was packaged in sizes ranging from 18mL credit cards, to bottles sized in 118, 236, 300 and 550 mL and 1000mL wall mounted dispenser refills. Pictures are available in the attached related file.

Use of a hand sanitizer contaminated with Burkholderia cepacia complex and Ralstonia pickettii, can range from no reaction to serious infections in a person with a hand wound or scrapes because the bacteria could enter the bloodstream, especially in patients with compromised immune systems. Health care professionals who use this contaminated hand sanitizer and tend to an at-risk patient, such as one with cystic fibrosis, could lead to adverse events ranging from a localized infection to lung or bloodstream infections, which could require patient hospitalization.

The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available. The product can be identified by examples of the product labels below. The product was manufactured from Feb. 1, 2020 until June 30, 2020, and distributed to selected retailers nationwide in the United States.

Durisan has provided written notification to its distributors and retailers and is alerting customers via this voluntary recall. Consumers that have the product which is being recalled are advised to destroy it immediately.

Consumers with questions regarding this recall can contact Durisan at 941-351-9114 [Call: 941-351-9114] , 8:30 am - 4:30 pm Eastern time, Monday through Friday or by e-mail at customerservice@durisan.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Check the full recall details on fda.gov

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

April 1, 2021 12:02 PM

“Company name: NANA Collection LLC
Brand name: PremierZen Platinum 5000, Triple SupremeZen Gold 3500
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and Tadalafil
FDA Recall date: April 01, 2021
Recall details: NANA Collection LLC is v... See Moreoluntarily recalling all lots of PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 to the consumer level. FDA analysis has found the PremierZen Platinum 5000 to contain undeclared Tadalafil and Triple SupremeZen 3500 to contain undeclared Tadalafil and Sildenafil. 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 Tadalafil and Sildenafil in PremierZen Platinum 5000 & Triple SupremeZen Gold 3500  renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall. Consumers with underlying medical issues who take PremierZen Platinum 5000 with Tadalafil and Triple SupremeZen Gold 3500 with undeclared Tadalafil and Sildenafil 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, NANA Collection LLC has not received any reports of adverse events related to this recall. This tainted PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 are marketed as dietary supplements for male sexual enhancement and are packaged in paper packaging with a pill blister, 1 capsule per package.  The affected PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 lots include all lot numbers to include GATCO 01671, GATCO 1805 with expiration date 12/30/2024. The product can be identified by the word ZEN stamped on the capsule along with PremierZen and Triple SurpremeZen written on the packaging.

PremierZen Platinum 5000 and Triple SupremeZen Gold 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. NANA Collection LLC is notifying its customers by this press announcement and via email of this recall.


Consumers that have PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 which are being recalled should discard the product. Consumers with questions regarding this recall can contact NANA Collection LLC by 201-773-8545 or nanastyle2014@gmail.com on Monday through Friday from 9am to 5pm, eastern time. 

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. 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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Reported By SafelyHQ.com User

March 31, 2021 8:00 PM

“Company name: Apotex Corp.
Brand name: Apotex Corp.
Product recalled: Guanfacine Extended-Release Tablets 2mg
Reason of the recall: Trace amounts of Quetiapine Fumarate
FDA Recall date: March 31, 2021
Recall details: Weston, Florida, Apotex Corp is voluntarily recalling three (3) lots of Guanfa... See Morecine Extended-Release Tablets 2mg to the consumer level due to trace amounts of Quetiapine Fumarate in one lot RX1663. Out of an abundance of caution, lots RX1662 and RX1664 are also included in the scope of this voluntary recall, as they were manufactured in the same campaign as lot RX1663.

Risk Statement: Administration of Guanfacine Extended-Release Tablets containing trace amounts of Quetiapine Fumarate to a patient can result in the possibility of hypersensitivity reaction and may potentially have additive effects in lowering blood pressure, sleepiness/sedation, and dizziness. Pediatric patients, pregnant patients and older adults may be more likely to experience low blood pressure and dizziness if exposed to the defective product.

To date, Apotex Corp has not received any reports of adverse events related to this recall. Guanfacine is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and can be used with other stimulant medications. Quetiapine is indicated for the treatment of Schizophrenia and other serious mental disorders such as Bipolar disorder manic episodes, Bipolar disorder, and depressive episodes.

The affected Guanfacine Extended-Release Tablets can be identified by NDC numbers stated on label of the product. The lot number and Expiration date are located to the left side of the product description on the label besides the 2D barcode. The affected lots were distributed in the USA between December 22, 2020 to March 19, 2021.

- Guanfacine Extended-Release Tablets. Pack Size: 100 Tablets. Strength: 2 mg. NDC Number: 60505-3928-1. UPC Code: 3 60505 39281 0. Lot Number / Expiry Date: RX1662 / Nov-22 | RX1663 / Nov-22 | RX1664 / Nov-22

The three (3) affected lots of Guanfacine extended-release tablets were distributed by Apotex nationwide in the USA to Wholesalers, Distributors, Warehousing Chains, Independent Retail Pharmacy and Retail Buying Group. Apotex Corp is currently notifying its affected direct account Wholesalers, Distributors, Warehousing Chains, Independent Retail Pharmacy and Retail Buying Group, via mail (FedEx Standard Overnight) and is arranging for return of all recalled product.

Patients who have received either of the three impacted lots of Guanfacine Extended-Release Tablets or have questions regarding this recall should contact their pharmacy. Individuals should not interrupt their therapy due to this notice. They should immediately contact their health care provider for medical advice and return the impacted product to Inmar Rx Solutions by contacting at the numbers provided in this press release.

Wholesalers, Distributors, Warehousing Chains, Independent Retail Pharmacy and Retail Buying Group should return the recalled product to the place of purchase. Anyone with an existing inventory of the recalled product should quarantine the recalled lots immediately. Customers who purchased the impacted product directly from Apotex can call Inmar Rx Solutions at 1-855-697-4722 (9:00am – 5:00-pm, EST Monday thru Friday), to arrange for their return.

Consumers with the affected units of Guanfacine Extended-Release Tablets, can contact Inmar Rx Solutions (“Inmar”) at 1-855-697-4722, to receive a recall/return packet including the Recall Stock Response Form, or you may obtain this form clsnetlink.comExternal Link Disclaimer

Consumers with questions regarding this recall can contact Apotex Corp. by phone at 1-800-706-5575 (8:30am –5:00pm, EST Monday thru Friday) or email address UScustomerservice@Apotex.com. 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.

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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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
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Reported By SafelyHQ.com User

March 23, 2021 5:59 PM

“All I received was the chain and straps not the chain saw how can I get my money back? I am 73 and got cheated out of $29.99 plus tax for a chain saw when all I received was a chain and I want my money back See Less
Reported By SafelyHQ.com User

March 17, 2021 11:00 AM

“Company name: PNHC, LLC d/b/a Heal the World
Brand name: Heal the World
Product recalled: Hand Sanitizer
Reason of the recall: Because they resemble water bottles; risk of ingestion
FDA Recall date: March 17, 2021
Recall details: Raleigh, North Carolina, PNHC, LLC, d/b/a Heal the World, is vol... See Moreuntarily recalling all lots of Heal the World hand sanitizer packaged in 9.6 fl. oz containers to the consumer level. The products are being recalled because they resemble 9.6ounce water bottles. The recall does not affect any other Hand Sanitizer products from PNHC, LLC and/or Heal the World.

- Heal the World Hand Sanitizer (9.6 FL. OZ (285 mL)). NDC: 73333-285-01. Lot Nos. SAA21, SAA24, SAA27, SAA22, SAA23, SAA29, SAA26, SAA28, SAA25, SAA32, SAA55, SAA56, SAA44, SAA60.

To date, PNHC, LLC, d/b/a Heal the World has received no reports of adverse reactions and no complaints have been received. Ingesting hand sanitizer, which is intended for topical use, could potentially result in alcohol toxicity. Symptoms of alcohol toxicity may range from lack of coordination, slowed or slurred speech, drowsiness to coma, which can be fatal. Furthermore, ingesting alcohol can affect the brain and cause impaired driving or operating heavy machinery. Alcohol can also interact with numerous drugs which may result in serious adverse effects. Ingesting alcohol by people with alcohol addiction may interfere with maintaining abstinence. Additionally, people with alcohol addiction may seek large amounts of ethanol-based hand sanitizers as a substitute.

The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available and is packaged in 9.6 ounce plastic bottles. The product can be identified by the bottle’s label pictured below. Product was distributed to selected retailers in the United States.

PNHC, LLC has provided notification to its distributors and retailers. Distributors and retailers that have product which is being recalled should stop distribution. While the product is not available for purchase and has not been available for several months, if a consumer has product which is being recalled he or she is advised to contact the entity who sold the product to consumer for return.

Consumers with questions regarding this recall can contact PNHC, LLC at 813-434-0741 from 9:00 am- 5:00 pm EST, Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

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.
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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
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Reported By SafelyHQ.com User