# FDA recall D-0388-2021

> **Bit & Bet LLC** · Class II · drug recall initiated 2021-03-24.

## Product

Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673.    Packaged in blister foil sheets in a box. Each box contains 10 capsules.

## Reason for recall

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0388-2021
- **Recalling firm:** Bit & Bet LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-03-24
- **Report date:** 2021-05-26
- **Termination date:** 2021-07-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cliffside Park, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0388-2021

## Citation

> AI Analytics. FDA recall D-0388-2021. Retrieved 2026-08-12 from https://api.ai-analytics.org/recall/D-0388-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*