Akkarco LLC of Lorton, VA, is recalling Ashfiat Alharamain Energy Support because the product contains undeclared Tadalafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE5) inhibitors.
Products containing tadalafil cannot be marketed as dietary supplements. Ashfiat Alharamain Energy Support is an unapproved new drug for which safety and efficacy have not been established.
Tadalafil is approved by the FDA only for use under medical supervision. Products containing this ingredient without proper authorization may pose potential health risks to consumers, particularly for individuals with underlying medical conditions or those taking certain medications. Possible adverse effects may include, but are not limited to, cardiovascular complications, blood pressure changes, dizziness, headache and other related symptoms.
The affected product(s) were distributed nationwide within the United States https://akkarco.com/ including third-party e-commerce marketplaces such as amazon.com.
The recalled product is packaged in glass bottles with an orange label, and includes the following code information:
Product & Brand Name: ASHFIAT ALHARAMAINUPC: 1234561870003Batch No: ENCOT24EXP: OCT, 2028
Product codes and expiration date scan be found on the product packaging backside.
The recall was initiated after Akkarco LLC was notified by the FDA of the sample results and received confirmation of an FDA online alert indicating the presence of Tadalafil.
To date, no confirmed adverse health events have been reported to the company in connection with the recalled product.
Consumers who have purchased the recalled product(s) should stop using the product immediately.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
