Premium OrgaZEN 7000 Capsules Recalled for Undeclared Sildenafil and Tadalafil
Premium OrgaZEN 7000 capsules distributed nationwide have been recalled because they were marketed without FDA approval and contain undeclared sildenafil and/or tadalafil, prescription drugs that pose serious health risks.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall for a drug product marketed without approval and containing undeclared prescription ingredients. Class I recalls are automatically assigned a severity score of 5 (Critical) per the rubric.
Plain-English summary
NSNY Distributor Inc is recalling Premium OrgaZEN 7000 capsules (1-count per blister card, UPC 0 40232 32555 7), distributed by Nutra Vita Co of Santa Fe Springs, California, and made in the USA. Approximately 2,600 capsules are affected across all lot codes.
The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and contains undeclared sildenafil and/or tadalafil. These are prescription medications that can cause serious adverse effects, especially in individuals taking certain other medications or with underlying health conditions.
Consumers who have purchased this product should discontinue use immediately and consult their healthcare provider if they have taken it, particularly if they have experienced any unusual symptoms or are on other medications. Healthcare providers should report any adverse events associated with this product to the FDA.
The recalled product
- Product
- Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in USA , UPC 0 40232 32555 7
- Manufacturer
- NSNY Distributor Inc
- Hazard
- undeclared-sildenafil
- undeclared-tadalafil
- unapproved-drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all lots
Distribution
Distributed nationwide across the United States.
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