- Company Announcement Date:
- March 31, 2021
- FDA Publish Date:
- April 05, 2021
- Product Type:
- Reason for Announcement:
Recall Reason Description
Undeclared Sildenafil and/or Tadalafil
- Company Name:
- Brand Name:
IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000
- Product Description:
Dietary Supplement for male sexual enhancement
Elmwood Park, NJ, QMART is voluntarily recalling all lots of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 to the consumer level. FDA analysis has found the products to be tainted with undeclared sildenafil and/or 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/or tadalafil in IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 renders them unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Risk Statement: Consumers with underlying medical issues who take IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 capsules with undeclared sildenafil and/or 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, QMART has not received any reports of adverse events related to this recall.
These tainted products are marketed as dietary supplements for male sexual performance enhancement and are packaged in cardboard blisters. The affected lots of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 include all lots. The product can be identified by the UPC codes in the table below which were distributed via internet and fulfilled by amazon at www.amazon.com. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.
|Product Name||Package Size||UPC|
|IMPERIAL Gold 2000||1 capsule||7 18122 04070 2|
|PremierZEN Extreme 3000||1 capsule||7 28175 42188 7|
|BURRO en PRIMAVERA 60000||2 capsules||6 38632 43105 5|
|IMPERIAL Platinum 2000||1 capsule||7 18122 04070 2|
QMART is notifying its distributors and customers by this press announcement and via e-mail of this recall. Consumers that have IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 which are being recalled should discard the products. Consumers with questions regarding this recall can contact QMART by (551) 252-8322 on Monday through Friday from 9am to 5pm, eastern time zone or by email at [email protected]. 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.