# FDA recall D-1206-2019

> **Brian P. Richardson** · Class I · drug recall initiated 2019-04-05.

## Product

Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.

## Reason for recall

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the treatment of male erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1206-2019
- **Recalling firm:** Brian P. Richardson
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-04-05
- **Report date:** 2019-04-24
- **Termination date:** 2022-01-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dallas, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1206-2019

## Citation

> AI Analytics. FDA recall D-1206-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1206-2019. Source: US FDA. Licensed CC0.

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