# FDA recall D-0641-2021

> **NSNY Distributor Inc** · Class I · drug recall initiated 2021-04-08.

## 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

## Reason for recall

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0641-2021
- **Recalling firm:** NSNY Distributor Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2021-04-08
- **Report date:** 2021-07-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Flushing, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0641-2021

## Citation

> AI Analytics. FDA recall D-0641-2021. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0641-2021. Source: US FDA. Licensed CC0.

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