PrimeZEN Black 6000 male enhancement capsules are being recalled after they have been found to be tainted with Sildenafil and Tadalafil. These contaminants can cause dangerous interactions with prescriptions drugs and can lead to a life-threatening hypotension (low blood pressure).
SUMMARY
Date of Recall:
Announced: February 13, 2023
Public Notification: February 13, 2023
Name(s) of Drug:
PrimeZEN Black 600
Company Name:
Volt Candy
Drug Indication:
Erectile Dysfunction
Product Description
Each capsule is packaged individually in a clear clamshell that is attached to a black, cardboard card. Capsules are black in color with ZEN printed on them.
Reason for Recall
The pills are contaminated with unapproved substances (Sildenafil and Tadalafil) which react with common medications used for heart conditions, diabetes and high cholesterol.
Impacts
Consumers experiencing an interaction between the pills and their medication may experience symptoms of hypotension (low blood pressure) including weakness, lightheadedness, fainting, confusion, blurred vision, nausea, vomiting and even DEATH. In particular, those who take the following medications are at high risk of interaction.
- Nitroglycerin
- Nitrostat
- Nitromist
- Nitrolingual Pumpspray
- Nitro-Bid
- Nitropress
- Nitroprusside
- Nitro-Dur
- Transderm-Nitro
- Nitro-Time
- Isosorbide Mononitrate
- Dinitrate
- Isordil
- Isordil Titradose
- Dilatrate-SR
- Amyl Nitrite
- Amyl Nitrate
Lot information
This recall pertains to one lot of the pills. Lot [NPINPB 1003] with expiration date 08/16/2025. The lot number and expiration date can be located in the upper right corner of the back side of the packaging.
Have you found that your supplement is part of the recall?
Here’s what you should do:
Consumers
If you find that your lot of supplements is part of this recall, do the following:
- STOP USING THE SUPPLEMENT IMMEDIATELY!
- Notify your physician if you have utilized the medication and have experienced any of the symptoms listed above.
- Continue to monitor your health for any adverse symptoms over the next week and notify your physician if any concerns are noted.
- Consumers may contact the manufacturer via email at info@voltcandy.com.
- If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled supplement.
Retailer
- Examine all inventory and remove stock that is affected by the recall immediately.
- Contact the manufacturer at info@voltcandy.com via email. Notify them of any recalled batches that have already been sold to consumers.
- Notify affected consumers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled supplement.
Wholesaler
- Examine all inventory and remove stock that is affected by the recall immediately.
- Contact the manufacturer via email at info@voltcandy.com. Notify them of any recalled batches that have already been shipped to retailers.
- Notify affected retailers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled supplement.
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