Alpha Male Plus Male Enhancer Fruit Chew Recall [US]


Alpha Male Plus Male Enhancer Fruit Chew Recall [US]

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US FlagUS/Silver Spring: Alpha Male Plus, a Tucson, Arizona establishment, recalls all current batch/lots of Alpha Male Plus Male Enhancer Fruit Chew Supplements from the American marketplace due to reported undeclared Tadalafil, an FDA approved drug 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/8Vk130rOqJz

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alpha-male-plus-issues-voluntary-nationwide-recall-alpha-male-plus-male-enhancer-due-presence

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

  • Alpha Male Plus Male Enhancer Fruit Chew Supplements, an unapproved drug product marketed, sold and delivered as dietary supplements for male sexual enhancement and packaged in one (1) strip per silver foil pouch within a cardboard box, and a UPC 8 60003 03770 6  [8 60003 74512 0]

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

==> 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, the tainted Alpha Male Plus Male Enhancer product was manufactured by Dr. Manuel Mascarenas M.D. in Tucson, Arizona located at 5190 E Farness Drive, Suite 104, 85712. His direct contact information is +1-520-795-7724 and 1+520-248-1964. Dr. Mascarenas is the originator and manufacturer of these products for the global market and his Web site address is http://www.alphamalexr.com. Alpha Male Plus was selected to act as the US distributor and distribute these products for the US market.

The FDA reports the Tadalafil ingredient was never disclosed or otherwise made known to its US distributor and was only discovered through FDA laboratory analysis. Dr. Manuel Mascarenas is solely responsible for the creation, formulation and proliferation of this product. Through the use of concealment, dishonest means and an unknowing third party, Dr. Mascarenas was able to begin distributing this mislabeled and potentially harmful product to the US market.

Further, the FDA says its analysis found these Alpha Male Plus Male Enhancer Fruit Chew Supplements reportedly contain Tadalafil. Because this drug is a FDA approved medications for the treatment of Male Erectile Dysfunction (“ED”), Benign Prostatic Hyperplasia (“BPH”) and certain other medical conditions, the presence of Tadalafil in this brand 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 Alpha Male Plus Male Enhancer Fruit Chew 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 Alpha Male Plus at +1-520-955-2015 from 9:00 AM to 5:00 PM Pacific Standard Time, Monday to Friday or by e-mail at brendanm@alphamaleplus.us.

==> 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 Alpha Male Plus Male Enhancer Fruit Chew, brand, please search for “Alpha Male Plus” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 14702-2021
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?
==> 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:
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Visit the Living Safely site:
==> http://www.LivingSafely.org/
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==> 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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E. & O. E.

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