# FDA recall D-1537-2019

> **NingBo Huize Commodity Co.,Ltd.** · Class III · drug recall initiated 2019-04-01.

## Product

Tootsie Roll POP RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

## Reason for recall

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

## Distribution

Foreign manufacturer located in China and distributed to seven consignees located in China.

## Key facts

- **Recall number:** D-1537-2019
- **Recalling firm:** NingBo Huize Commodity Co.,Ltd.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-04-01
- **Report date:** 2019-08-07
- **Termination date:** 2023-06-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Yuyao, N/A, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1537-2019

## Citation

> AI Analytics. FDA recall D-1537-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1537-2019. Source: US FDA. Licensed CC0.

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