Active Male Dietary Supplement Recall [US]


Active Male Dietary Supplement Recall [US]

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US FlagUS/Silver Spring: Natural Remedy Store, a San Antonio, Texas establishment, recalls all current batch/lots of Active Male Dietary Supplement Capsules due to suspected undeclared Tadalafil, an existing FDA approved drug for certain medical conditions and legally available only under prescription from a licensed physician. The undeclared presence of this medication can pose a serious health and safety hazard for some people.

FDA: http://ht.ly/W7RA30qrMHX

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/natural-remedy-store-issues-voluntary-worldwide-recall-active-male-due-presence-undeclared-tadalafil

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

  • Active Male Dietary Supplements, sold by Natural Remedy Stores in 500 mg capsules with a batch/lot designation of Nd6332

Please consult the photograph above for details of the drug’s packaging, design and retail presentation.

==> No barcodes, UPCs, item numbers or other identification numbers were listed with this recall notification.

According to the FDA, its analysis found these Dietary Supplement products to be tainted with Tadalafil, an FDA approved drug for the treatment of erectile dysfunction. The presence of Tadalafil in the Active Male Dietary Supplements renders them new, 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 the recalled Supplements could lower blood pressure to dangerous levels that could be life-threatening. To date, Natural Remedy Store has not received any reports of adverse events related to this recall.

==> 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 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 poisonings.

If you have any questions about this recall, please contact the Natural Remedy Store at 1-210-798-5433 from 10:00 AM to 6:00 PM Pacific Standard Time, Monday to Saturday. You can also reach the company by e-mail at natremedies@att.net.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Natural Remedy Store, please search for “Natural Remedy” 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 Active Male brand, please search for “Active Male” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 12831-2020
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?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food or drug you purchased in the US [external: new window opens]:
==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

We welcome your feedback:
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E. & O. E.

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