# FDA recall D-0788-2021

> **China Gel Inc** · Class II · drug recall initiated 2021-03-10.

## Product

CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as  a) 2 OZ (56.8g) tube, NDC 76305-300-13;   b) 4 OZ (113.5g) jar, UPC 6 87806 10004 2, NDC 76305-300-02;   c) 6 OZ (170 g) tube, UPC 6 87806 10006 2, NDC 76305-300-03;   d) 8 OZ (226.8g) jar, UPC 6 87806 10008 2, NDC 76305-300-04;   e) 16 OZ (453.6g), Bottle w/ Pump, UPC 6 87806 10016 7, NDC 76305-300-03;   f) 128 OZ (3.78L) Gallon, UPC 6 87806 10128 7, NDC 76305-300-06;   Distributed by: CHINA-GEL LLC, Arlington Heights, IL 60005,

## Reason for recall

CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.

## Distribution

Distributed Nationwide in the USA as well as Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, United Kingdom

## Key facts

- **Recall number:** D-0788-2021
- **Recalling firm:** China Gel Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2021-03-10
- **Report date:** 2021-09-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Arlington Heights, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0788-2021

## Citation

> AI Analytics. FDA recall D-0788-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/D-0788-2021. Source: US FDA. Licensed CC0.

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