INDIANAPOLIS (WXIN) – Another dietary supplement is being recalled because it is tainted with the active ingredient in the prescription drug Cialis.
The Food and Drug Administration (FDA) says the recall involves two lots of Proper Trade LLC/My Stellar Lifestyle’s Wonder Pill. The recall was initiated after Amazon notified the company that laboratory analysis has found the product to be tainted with tadalafil.
The recall comes as the FDA is warning companies that selling products that contain undisclosed or hidden prescription medication violates federal law. In early July, the FDA sent warning letters to four companies that sold honey products that contained undeclared active ingredients, including sildenafil and tadalafil.
Sildenafil and tadalafil are the active drug ingredients found in Viagra and Cialis, respectively. They are restricted to use under the supervision of licensed health care professionals. The FDA said these undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.
The product is marketed as a dietary supplement for male sexual enhancement and is packaged in 10-count blisters co-packaged in a carton, ASIN B0B6CWC9NK, and packaged in a 60-count bottle. The affected lots include lot numbers 20210912 & 31853-501, and expiration date 09/24.
Because the products are listed as dietary supplements, they are regulated by the FDA as food, not drugs. Under the law, the FDA does not have the authority to approve dietary supplements for safety and effectiveness or approve their labeling. It is the responsibility of the company to make sure its products meet safety standards and are not violating the law.
However, tadalafil and sildenafil products are excluded from the dietary supplement definition. Their presence makes the products unapproved drugs for which safety and efficacy have not been established.
Anyone with the recalled capsules should stop using them and return them. Anyone with questions can contact Proper Trade LLC by phone number (732)-242-4711 or e-mail at email@example.com Monday thru Friday from 9 a.m. to 5 p.m. EST.
Anyone who experiences an adverse event, also known as a side effect or bad reaction, should report it to their health care professional and FDA. The FDA says even a single adverse event report can help them identify a potentially dangerous product and possibly remove it from the market.
Adverse reactions or quality problems may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178