Volt Candy Recalls PrimeZen Black 6000 Capsules

Editor
February 13, 2023
17:42
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Medical Recalls

Junp MegMan Performance Booster Capsules

PrimeZEN Black 6000

Volt Candy is voluntarily recalling one lot of PrimeZen Black 6000, 2000 mg capsule, to the consumer level. FDA analysis has found PrimeZen Black 6000 capsules to be tainted with sildenafil & tadalafil. Sildenafil and tadalafil are phosphodiesterase (PDE-5) inhibitors found in FDA-approved products for the treatment of male erectile dysfunction. The presence of sildenafil, tadalafil in PrimeZen Black 6000 capsules renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.

Product was distributed Nationwide to consumers online at the website info@voltcandy.com. PrimeZen Black 6000 is marketed as a dietary supplement for male enhancement and is packaged in a blister card with one capsule, UPC code: 728175521891. The affected PrimeZen Black 6000 includes the following lot number [NPINPB 1003] with an expiration date of 08/16/2025. The product can be identified by the card color in black with the name on it PrimeZen Black 6000.

Volt Candy is notifying their online customers by email and is arranging for return of all recalled products. Consumers or those with product in their possession should stop using and return the affected product PrimeZen Black 6000, lot number [NPINPB 1003] Expiration date 08/16/2025 to this address:

Volt Candy

324 S. Diamond Bar Blvd

#212

Diamond Bar, CA 91765

Source: FDA

Consumer Contact: -

Consumers with questions regarding this recall can contact Volt Candy by e-mail info@voltcandy.com on weekdays between 9am-5pm PST. 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.

Risk Statement

PrimeZen Black 6000 capsules containing sildenafil and tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are most at risk from these products. Volt Candy has not received reports of state adverse events or injuries to date.

Post Tags

PrimeZen, PrimeZen Black 6000, PrimeZen Black 6000 recall, PrimeZen recall, sildenafil, tadalafil, Volt Candy, Volt Candy recall

Report a Problem With This 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
Complete a paper Voluntary MedWatch form that can be mailed to the FDA.
https://www.fda.gov/safety/report-problem-fda
Call an FDA Consumer Complaint Coordinator.