Vold Candy issues a consumer-level recall of PrimeZen Black 6000, 2000 mg capsule. The recall is being initiated after FDA analysis found that PrimeZen Black 6000 capsules of sildenafil & tadalafil. Sildenafil and tadalafil are phosphodiesterase (PDE-5) inhibitors only found in FDA-approved drugs for erectile dysfunction.
Therefore, the presence of these inhibitors in the recalled capsule renders it an unapproved drug for which safety and efficiency have not been established.
Risk Statement
The presence of sildenafil and tadalafil in PrimeZen Black 6000 capsules could cause interaction with other nutrients found in prescription drugs. This interaction could result in a significant drop in blood pressure for the patients and could be life-threatening.
People who take nitrates often have high blood pressure, diabetes, heart disease, and high cholesterol. The male population with cardiac conditions are highly at risk as they’re more likely to use these capsules. To date, Volt Candy has not received any reports of reactions associated with using this drug.
PrimeZen Black 6000 capsules are sold as dietary supplements for male enhancement. They’re packaged in a blister card containing one capsule and bear UPC code: 728175521891. Volt Candy distributed this product online nationwide through their website [email protected].
The affected products contain lot number [NPINPB 1003] and an expiry date of an expiration date of 08/16/2025. It can also be recognized by the card color in black with the name PrimeZen Black 6000 on it.
Volt Candy is sending notifications about the recall to all its online consumers by mail and is arranging for the return of the affected products. Consumers who have the PrimeZen Black 6000, lot number [NPINPB 1003], Expiration date 08/16/2025, in their possession should stop using it immediately and return it to the address below:
Volt Candy,
324 S. Diamond Bar Blvd,
#212.
Diamond Bar, CA 91765
Consumers with questions about the recall can send an email to Vold Candy through [email protected] Monday through Friday from 9 am to 5 pm PST. Consumers who have experienced any problems as a result of using the PrimeZen Black 6000 capsules should contact their healthcare providers immediately.
Any adverse reactions or quality problems can be reported to FDA’s MedWatch Adverse Event Reporting program through:
- Online: www.fda.gov/medwatch/report.htm
- Regular mail: Download the form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form.
- Fax: 1-800-FDA-0178
