Ummzy Krazy Night, Shogun-X & Thumbs Up Recall [US]


Ummzy Thumbs Up, Shogun-X & Krazy Night Recall [US]

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US FlagUS/Silver Spring: Ummzy LLC, a Palisades Park, New Jersey establishment, recalls all current batch/lots of Krazy Night Dietary Supplement Capsules, Shogun-X 15000 mg Dietary Supplement Capsules and Thumbs Up 7 Red 70K Dietary Supplement Capsules from the American marketplace due to reported undeclared Sildenafil, Tadalafil and Vardenafil, three (3) FDA approved drugs for the treatment of Male Erectile Dysfunction (“ED”), Benign Prostatic Hyperplasia (“BPH”) and certain other medical conditions and in a class of drugs called Phosphodiesterase (“PDE-5”) Inhibitors with consequential risks of dangerous low blood pressure, injury and possible life-changing complications, all serious health and safety hazards.

FDA: http://ht.ly/TkLw30rDCMy

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ummzy-llc-issues-voluntary-nationwide-recall-thumbs-7-red-70k-shogun-x-15000mg-and-krazy-night-due

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Dietary Supplement products are subject to this recall:

  • Thumbs up 7 Red 70K Dietary Supplements, sold in blister foil sheets of 10 capsules; affected batch/lots: all current batch/lots
  • Shogun-X 15000 mg Dietary Supplements, sold in blister foil sheets of 10 capsules; affected batch/lots: all current batch/lots
  • Krazy Night Dietary Supplements, sold in blister foil sheets of 10 capsules; affected batch/lots: all current batch/lots

Please consult the photograph above for details of the Supplement’s packaging, design and retail presentation. Additional images of the recalled Dietary Supplement products can be found on the Web site above.

No barcodes, UPCs, NDCs, DINs, item numbers, best-before date codes, manufacturing date codes, production dates, expiry dates, regulatory approval designations, registration numbers, agency approval designations or other identification numbers were listed with this recall notification

According to the FDA, its analysis found the recalled Krazy Night, Shogun-X 15000 mg and Thumbs Up 7 Red 70K Supplement Capsules contain Sildenafil, Tadalafil and Vardenafil. Because these drugs are FDA approved medications for the treatment of Male Erectile Dysfunction (“ED”), Benign Prostatic Hyperplasia (“BPH”) and certain other medical conditions, the presence of Sildenafil, Tadalafil and/or Vardenafil in these brands of Dietary Supplement products renders them unapproved drugs for which safety and efficacy have not been established, therefore subject to recall.

Men with Diabetes, High Blood Pressure, High Cholesterol or Heart Disease, may be on medications that if taken with these products could lower blood pressure to dangerous levels that could be life threatening. The products affected are aimed at men who have Diabetes, High Blood Pressure, High Cholesterol or Heart Disease.

==> Never depend on your senses of sight, smell, taste or touch to confirm drug poisoning, adulteration or contamination. If in doubt about the safety of any drug, return it to your retailer for refund or drop it off at a local pharmacist for proper disposal, making sure neither small children nor household pets can access the suspect drugs.

If you believe you have purchased or have in your possession any of the recalled Thumbs Up 7 Red 70K, Shogun-X 15000 mg or Krazy Night Dietary Supplements, please do not consume them directly nor use them as an ingredient in another preparation, especially with other medications or alcohol. Instead, return the Supplements to the store or online outlet where you purchased it for a full refund.

==> If you have a medical emergency, please contact 9-1-1, your closest hospital or emergency center equipped to handle drug incidents including, but not limited to, lowered blood pressure.

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US CDC Coronavirus Tips___________________________________________________________

If you have any further questions, comments or complaints about this recall, please contact Ummzy LLC at +1-201-416-9325 from 9:00 AM to 5:00 PM Eastern Standard Time, Monday to Friday, on the Web at http://www.ummzyllc.com or by e-mail at ysknabe75@gmail.com.

==> To see other recalls and notifications caused by suspected Sildenafil contamination, please search for “Sildenafil” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Tadalafil contamination, please search for “Tadalafil” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Vardenafil contamination, please search for “Vardenafil” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Ummzy LLC, please search for “Ummzy” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold under the Krazy Night brand, please search for “Krazy Night” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold under the Thumbs Up brand, please search for “Thumbs Up” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold under the Shogun-X brand, please search for “Shogun” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 14289-2021
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
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General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
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Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food product you purchased in the UK [external: new window opens]:
==> https://www.food.gov.uk/enforcement/report-problem
Search for a recalled product on the UK FSA Web site [external: new window opens]:
==> https://www.food.gov.uk/news-updates/news

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