** NAFDAC joins the Federal Ministry of Health and Social Welfare, nutrition partners, and the rest of the world in celebrating World Breastfeeding Week 2024 from 1st to 7th August. The theme for this year is ' Closing the gap: Breastfeeding Support for All'. Let us all join hands to protect, promote, and support breastfeeding. Happy World Breastfeeding Week! ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6
** NAFDAC joins the Federal Ministry of Health and Social Welfare, nutrition partners, and the rest of the world in celebrating World Breastfeeding Week 2024 from 1st to 7th August. The theme for this year is ' Closing the gap: Breastfeeding Support for All'. Let us all join hands to protect, promote, and support breastfeeding. Happy World Breastfeeding Week! ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6
  1. Home
  2. »
  3. Recalls and Alerts
  4. »
  5. Public Alert No. 030/2021 – Alert on Recall of All Unexpired Lots of Alpha Male…

Public Alert No. 030/2021 – Alert on Recall of All Unexpired Lots of Alpha Male Plus Male Enhancer fruit chews by Alpha Male Plus Due to the Presence of Undeclared Tadalafil and Sildenafil

,

The National Agency for Food and Drug Administration and Control has been informed by the U.S. Food and Drug Administration that Tucson, AZ, Alpha Male Plus is voluntarily recalling all lots of unexpired Alpha Male Plus Male Enhancer fruit chews. The result of analysis by FDA found the product to contain undeclared tadalafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in FDA approved product for the treatment of male erectile dysfunction.

The presence of tadalafil in Alpha Male Plus Male Enhancer renders the product an unapproved drug for which safety and efficacy have not been established.

Alpha Male Plus Male Enhancer fruit chew is marketed as a dietary supplement for male sexual enhancement and sold online.

Possible Risk

The undeclared tadalafil ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Consumers with underlying medical issues who take Alpha Male Plus Male Enhancer with undeclared tadalafil may experience serious health risks as the PDE-5 inhibitors may interact with nitrates found in some of their prescription drugs.

Product Detail: The details of the recalled products are as follows;

Product Name: Alpha Male Plus Male Enhancer fruit chew, Alpha Male Plus, Dietary Supplementary

Product Description: Alpha Male Plus is packaged in 1strip per foil pouch within a cardboard box.

UPC:

Product Manufacturer: Alpha Male Plus

Affected Lots: All lots

Product Image

 

NAFDAC implores consumers to stop the purchase and use of Alpha Male Plus. Members of the public in possession of the implicated product are implored to handover product to the nearest NAFDAC office.

Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to using the implicated product.

NAFDAC encourages healthcare professionals, consumers and patients to report adverse events related to the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via pharmacovigilance@nafdac.gov.ng, E- reporting platforms available on the NAFDAC website or via the Med- safety application available for download on android and IOS stores.

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

Was this helpful?

Yes
No
Thanks for your feedback!

More Actions