Premium OrgaZEN 7000 capsule recalled over undeclared sildenafil
- Recall date
- April 8, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- NSNY Distributor Inc recalls Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in US…
- Recall number
- D-0641-2021
- FDA classification
- Class I
- Brand / firm
- NSNY Distributor Inc
- Sold / distributed
- USA Nationwide
Why it was recalled
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
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
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