- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Dietary Supplements
- Reason for Announcement:
Recall Reason DescriptionUndeclared Sildenafil and Tadalafil
- Company Name:
- Brand Name:
Brand Name(s)PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000 capsules
- Product Description:
Product DescriptionDietary Supplement for male sexual enhancement
Irving, Texas, Miracle8989 is voluntarily recalling all lots PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000, capsules to the consumer level. FDA analysis has found the products to contain undeclared sildenafil and tadalafil. Sildenafil and Tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The presence of Sildenafil and Tadalafil in PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000 renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.
Risk Statement: Consumers with underlying medical issues who take PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000 with undeclared Sildenafil and Tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Ebay Seller Annie Cho has not received any reports of adverse events related to this recall.
The tainted PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000 products are marketed as dietary supplements for male sexual enhancement and is packaged in 1 count blister cards. The affected PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000 include all lot numbers and all expiration dates. The product can be identified by the product name and the UPC codes below distributed nationwide via internet.
|PremierZen Gold 7000||728175421832|
|PremierZen Platinum 8000||728175421832|
|MaxxZEN Platinum 12000||718122040728|
Miracle8989 is notifying its distributors and customers by sending eBay messages and is arranging for return of all recalled products. Consumers that have PremierZen Gold 7000, PremierZen Platinum 8000, and MaxxZEN Platinum 12000 which is being recalled should stop using.
Consumers with questions regarding this recall can contact Annie Cho from Miracle8989 at 972-799-0080, Monday - Friday from 09:00 – 17:00 CST or e-mail email@example.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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.
- 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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company Contact Information
- Annie Cho, Miracle8989