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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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Thumbs Up 7, Shogun-X, 69MODE Supplements - recalled due to undeclared Sildenafil, Tadalafil, Vardenafil, USA

March 31, 2021 12:02 PM

United States

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 lots 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

Reported By SafelyHQ.com User
More incidents from:
Drugs
Recall
United States

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April 5, 2021 5:00 PM

“Company name: QMART
Brand name: IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and/or Tadalafil
FDA Recall date: April 05, 2021
Recall det... See Moreails: Company Announcement Elmwood Park, NJ, QMART is voluntarily recalling all lots of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 to the consumer level. FDA analysis has found the products to be tainted with undeclared sildenafil and/or 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/or tadalafil in IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 renders them unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall. Risk Statement: Consumers with underlying medical issues who take IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 capsules with undeclared sildenafil and/or 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, QMART has not received any reports of adverse events related to this recall. These tainted products are marketed as dietary supplements for male sexual performance enhancement and are packaged in cardboard blisters. The affected lots of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 include all lots. The product can be identified by the UPC codes in the table below which were distributed 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.
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

April 7, 2021 11:00 AM

“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: Cliffside Park, NJ, Yol... See Moreo Studio is voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Black 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 Black 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 Black 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 Black 5000, & Triple SupremeZEN Plus 3500 include all lots. PremierZEN Extreme 3000, PremierZEN Black 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 Black 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. 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
SMB Screener

April 9, 2021 6:05 PM

“Company name: NS NY Distributor Inc
Brand name: NS NY Distributor Inc
Product recalled: Premium Orgazen 7000 and Ginseng Power 5000 capsules
Reason of the recall: Undeclared Sildenafil and/or Tadalafil
FDA Recall date: April 09, 2021
Recall details: Company Announcement NS NY Distributor Inc is... See Morevoluntarily recalling all lots within expiry of Premium Orgazen 7000 and Ginseng Power 5000 capsules to the consumer level. FDA  analyses has found the products to contain undeclared sildenafil and/or tadalafil. Sildenafil and tadalafil are known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The presence of sildenafil and/or tadalafil in Premium OrgaZen 7000 and Ginseng Power 5000 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 Premium OrgaZen 7000 capsules and Ginseng Power 5000 with undeclared sildenafil and/or 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, NS NY Distributor Inc has not received any reports of adverse events related to this recall.

These tainted products are marketed as a dietary supplements for male sexual enhancement and are packaged in a single capsule blister foil sheet and sold in lots of 3 capsules, 5 capsules and 10 capsules. The affected lot numbers of Premium OrgaZen 7000, UPC 0 40232 18144 3, and Ginseng Power 5000, UPC 0 40232 18144 3 include all lots. Premium OrgaZen 7000 and Ginseng Power 5000 were distributed nationwide in the USA via the internet by seller account Beauty.Kor. and fulfilled by amazon at www.amazon.com.

NS NY Distributor Inc is notifying customers who purchased through Amazon seller account Beauty.Kor by this press announcement. Consumers that have Premium OrgaZen 7000 and Ginseng Power 5000 which are being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact NS NY Distributors Inc by email at NSNYdistributors@gmail.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.

- 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

April 12, 2021 1:00 PM

“Company name: J. M. Smucker Co.
Brand name: Meow Mix®
Product recalled: Meow Mix® Original Choice Dry Cat Food
Reason of the recall: Potential Salmonella Contamination
FDA Recall date: April 12, 2021
Recall details: Orrville, OH – The J. M. Smucker Co. today announced a limited, voluntary recal... See Morel of two lots of Meow Mix® Original Choice Dry Cat Food (30LB bag) due to potential salmonella contamination. The Company has received no reports of pet illness or adverse reaction and has issued this recall out of an abundance of caution.

The impacted products were sold at select Walmart stores in IL, MO, NE, NM, OK, UT, WI, and WY. No other Meow Mix® products are impacted by this recall. If pet parents have products matching the following description in their possession, they should stop feeding it to their cats and dispose of it immediately. This information can be found on the bottom and back of each bag.

- Meow Mix® Original Choice Dry Cat Food (30 LB Bag). Retail UPC Code: 2927452099. Lot Code: 1081804. Best If Used By Date: 9/14/2022
- Meow Mix® Original Choice Dry Cat Food (30 LB Bag). Retail UPC Code: 2927452099. Lot Code: 1082804. Best If Used By Date: 9/15/2022

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

4 days after 1st Moderna vacx, Boston, MA, USA

Symptoms: Fever Cramps Headache Chills Joint Pain Muscle Pain
Boston, MA, USA

April 19, 2021 9:42 PM

“Moderna vacx or tasting (approx tablespoon perhaps-spoiled chicken salad) After this questionnaire I think my symtoms may have been a delay result of the vaccine.
Joint and muscle aches ALL over, chills, headache,abdominal cramp-like pain, temp max'd at 101.6° ... Took two caps Tylenol at 24 hrs.... See MoreSlept thru night awoke next morning (.. All symptoms completely gone! See Less
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Covid guidelines, DICK'S Sporting Goods, Broadway, Saugus, MA, USA

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Symptoms: Fever Headache Joint Pain
Hollywood, FL, USA

April 19, 2021 9:13 PM

“1st shot went relatively well. Had only minor tightness of throat for few minutes, felt light headed, and then felt feverish for a few days. Had join pain for a few days, but it got better later. Felt much better overall in a few days, better than before the shot. The second shot went well also, no... See Moretightness in the throat, no light headed, only soreness of arm for about two days. However, after one week, getting headaches/ mild migranes that don't go away and I don't really suffer from these. Had no major changes in routine or sleep habit to attribute to it. Headaches got worse after one week being vaccinated. Also, had a few episodes of weird symptoms I had never felt before- like if the heart skipped a beat... If it will continue, I will address this with my doctor. At this point, sharing, so that if anyone else has similar symptoms, we can bring it to the attention it needs. Overall, feel better than before getting the shot. I suspect I might have had long haul symptoms from possible Covid in March 2020- no tests were available to me to confirm the positivity then, but had many weird illnesses that are better now. The irregular heart beat/shortness of breath on occasion (only one to two seconds) concerns me a little. At this point, still happy I got the shot as I'm in the high risk category from complications and could not risk not getting vaccinated. See Less
Reported By SafelyHQ.com User

April 19, 2021 9:01 PM

“Company name: Tenacore LLC
Brand name: Tenacore LLC
Product recalled: 2001 Tenacore Replacement CareFusion Alaris 8100 bezels
Reason of the recall: Potentially weakened elastic
FDA Recall date: April 19, 2021
Recall details: Company Announcement On February 24th, 2021, Tenacore LLC initiated a... See Morenationwide recall of 2001 Tenacore replacement CareFusion Alaris 8100 bezels due to potentially weakened plastic. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (e.g., external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion. There is a related recall initiated by Becton Dickinson (BD). Information regarding that recall can be found using the following link: Becton Dickinson (BD) (CareFusion 303, Inc.) Recalls Alaris Pump Module Model 8100 Bezel Assembly Which Could Result in Free Flow, Over-Infusion, Under-Infusion, or Interruption of Infusion | FDA Consumers who have: Tenacore bezel parts (part number TIPA-8100-4410) with timestamp 5 and/or timestamp 6 should stop the distribution and use of these and return them to Tenacore LLC.
Alaris 8100 units that were serviced by Tenacore, or purchased from Tenacore between July 2020 and Feb 2020, should be inspected per the instructions described below to ensure that your device is not impacted. If it is, please return your device to Tenacore LLC.
Recalled bezels were manufactured from May 2020 to June 2020 and distributed from July 2020 through Feb 2021. The following products have been recalled:
Check the full recall details on fda.gov
Source: FDA
See Less
Reported By SafelyHQ.com User

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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

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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

J&J one shot vaccine, Valencia, Santa Clarita, CA, USA

Symptoms: Nausea Fever Headache Chills Soreness
Valencia, Santa Clarita, CA, USA

April 5, 2021 7:15 PM

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March 25, 2021 11:00 AM

“Company name: Zydus Pharmaceuticals Inc.
Brand name: Zydus Pharmaceuticals
Product recalled: Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials
Reason of the recall: Due to Crystalization
FDA Recall date: March 25, 2021
Recall details: Pennington, NJ, Zydus Pharmaceuticals (USA) Inc. i... See Mores voluntarily recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials, to the Hospital/User level after receiving several complaints of crystallization in vials.

Administration of crystalized Acyclovir Sodium Injection, 50 mg/mL has a potential of life-threatening adverse consequences including injection site inflammation of a vein and local reactions, damage and/or obstruction of blood vessels, which could induce clots, particularly in the lungs, the passage of the particulate matter into the bloodstream may lead to clots resulting in stroke, heart attack, decreased liver or kidney function or death of tissues or cells.

To date, Zydus Pharmaceuticals (USA) Inc. has not received any reports of adverse events related to this product recall. Acyclovir Sodium Injection, 50 mg/mL is indicated for the treatment of herpes simplex infections in immunocompromised patients, severe initial clinical episodes of herpes genitalis in immuno-competent patients, herpes simplex encephalitis, neonatal herpes simplex virus infection and varicella-zoster (shingles) infections in immunocompromised patients.

The product is packaged in single-dose glass vials and was distributed nationwide in the USA to Cardinal Health, Amerisourcebergen Drug Corporation and Morris & Dickson Company LLC. The affected Acyclovir Sodium Injection, 50 mg/mL lots include the following lot numbers and expiration dates:

- Acyclovir Sodium Injection, 50 mg/mL, 20 mL. Carton NDC Number: 68382-049-10. Vial NDC Number: 68382-049-01. Lot Number: L000155. Expiry Date: Dec 2021. Pack Size: 10x20 mL, Single-Dose Vial pack.

- Acyclovir Sodium Injection, 50 mg/mL, 20 mL. Carton NDC Number: 68382-049-10. Vial NDC Number: 68382-049-01. Lot Number: L000156. Expiry Date: Jan 2022. Pack Size: 10x20 mL, Single-Dose Vial pack.

- Acyclovir Sodium Injection 50 mg/mL, 10 mL. Carton NDC Number: 68382-048-10. Vial NDC Number: 68382-048-01. Lot Number: L000126. Expiry Date: Dec 2021. Pack Size: 10x10 mL, Single-Dose Vial pack.

- Acyclovir Sodium Injection 50 mg/mL, 10 mL. Carton NDC Number: 68382-048-10. Vial NDC Number: 68382-048-01. Lot Number: L000127. Expiry Date: Dec 2021. Pack Size: 10x10 mL, Single-Dose Vial pack.

Zydus Pharmaceuticals (USA) Inc. has notified its distributors and customers by email and FedEx overnight courier service and is arranging for the return of all recalled Acyclovir Sodium Injection, 50 mg/mL lots. Hospitals that have the product which is being recalled should stop using it immediately and call our recall coordinating center at 1-855-671-5023 [Call: 1-855-671-5023] Monday – Friday (excluding holidays), 9:00 am to 5:00 pm EST.

Consumers with questions regarding this recall can contact Zydus Pharmaceuticals (USA) Inc. by phone: 1-877-993-8779 [Call: 1-877-993-8779] or by email: medicalaffairs@zydususa.com Monday – Friday (excluding holidays), 9:00 am to 5:00 pm EST. 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

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. .
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Reported By SafelyHQ.com User

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