Premium OrgaZen & Ginseng Power Supplement Recall [US]

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US/Silver Spring: NS NY Distributor Inc. recalls all current batch/lots of Premium OrgaZen 7000 and Ginseng Power 5000 Dietary Supplements from the American marketplace due to reported undeclared Sildenafil and Tadalafil, two 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/tLLD30rEos8

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ns-ny-distributor-inc-issues-voluntary-nationwide-recall-premium-orgazen-7000-and-ginseng-power-5000

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

• The recalled Premium OrgaZen 7000 and Ginseng Power 5000 Supplements were marketed and sold as nutritional enhancement supplements for male sexual enhancement and are packaged in blister foil sheets of three (3) capsules, five (5) capsules or ten (10) capsules. Both of the recalled Dietary Supplements were distributed and sold over the Web through Amazon US nationwide with the Premium OrgaZen 7000 Supplements having a UPC of 0 40232 18144 3 while the Ginseng Power 5000 had a UPC of 0 40232 18144.

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 item numbers, 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 these Premium OrgaZen 7000 and Ginseng Power 5000 Supplements contain Sildenafil and Tadalafil. 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 and Tadalafil 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 Premium OrgaZen 7000 and/or Ginseng Power 5000 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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If you have any further questions, comments or complaints about this recall, please contact NS NY Distributor Inc. by e-mail NSNYdistributors@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 for products manufactured, marketed and/or sold under the Premium OrgaZen brand, please search for “Premium OrgaZen” 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 Ginseng Power brand, please search for “Ginseng Power” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 14314-2021
Want to read more about this recall?
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General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
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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]:
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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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