Energy supplement recalled because of undeclared erectile dysfunction drug
Akkarco LLC of Lorton, Virginia, is recalling Ashfiat Alharamain Energy Support because the product contains undeclared Tadalafil, an ingredient in products approved by the FDA for the 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 a new, unapproved medicine whose safety and effectiveness 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 people with underlying health conditions or those taking certain medications. Possible adverse reactions may include, but are not limited to, cardiovascular complications, changes in blood pressure, dizziness, headache, and other related symptoms.
The affected product(s) were distributed nationwide in 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 and brand name: ASHFIAT ALHARAMAIN
- UPC: 1234561870003
- Batch number: ENCOT24
- EXP: OCT 2028
Product codes and expiration date can be found on the back of the product packaging.
The recall was initiated after Akkarco LLC was notified by the FDA of the sample results and received confirmation of an FDA advisory. online alert indicating the presence of Tadalafil.
To date, no confirmed adverse health effects have been reported to the company in connection with the recalled product.
Consumers who purchased the recalled product(s) should immediately stop using it.
Adverse reactions or quality problems encountered during 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.
