Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
WASHINGTON — Akkarco LLC, based in Lorton, Virginia, has announced a nationwide recall of its Ashfiat Alharamain Energy Support product after federal regulators discovered it contained undeclared tadalafil, a prescription medication used for treating erectile dysfunction.
The U.S. Food and Drug Administration stated that the presence of tadalafil renders the product illegal to market as a dietary supplement, classifying it as an unapproved new drug whose safety and efficacy have not been verified. Tadalafil, a phosphodiesterase type 5 inhibitor, is only FDA-approved for use under medical supervision and may pose health risks, especially for individuals with pre-existing medical conditions or those on certain medications.
According to the FDA, potential side effects may include cardiovascular issues, fluctuations in blood pressure, dizziness, and headaches.
The recalled product was distributed across the nation, including through third-party online platforms like Amazon. It is packaged in a glass bottle with an orange label, identified as Ashfiat Alharamain Energy Support, UPC 1234561870003, batch number ENCOT24, and has an expiration date of October 2028. The batch and expiration details are located on the back of the packaging.
Akkarco stated that it began the recall after being alerted by the FDA and receiving confirmation through an agency notice regarding the presence of tadalafil in the product. The company also mentioned that no confirmed adverse health incidents related to the product have been reported so far.
Customers who bought the product are urged to cease usage right away and adhere to the return or disposal guidelines given by the seller or distributor. Questions regarding the recall can be sent to United Legal Experts, who are managing the recall on behalf of Akkarco. The recall is taking place with the FDA’s awareness, and Akkarco has stated that it is collaborating with its partners and sales platforms to withdraw the impacted product from the market.
