China-Gel Topical Pain Reliever Recall Due to Manufacturing Contamination
China Gel Inc is recalling China-Gel (menthol and camphor) topical pain reliever products due to contamination with B. cepacia found in the manufacturing facility where the product was made.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this as a Class II recall. B. cepacia is a high-risk pathogen that can cause serious infection, particularly in immunocompromised individuals. Although no illnesses have been reported in the source text, the potential for harm from this environmental contaminant in a topical product warrants a High severity rating.
Plain-English summary
China Gel Inc is recalling China-Gel (camphor 3% and menthol 5%) topical pain reliever products in multiple package sizes, including 2 oz tubes, 4 oz jars, 6 oz tubes, 8 oz jars, 16 oz bottles with pump, and 128 oz gallon containers. A total of 92,472 units are affected by this recall.
The recall was initiated because the product was manufactured in a facility where contamination with B. cepacia was identified in other products. This represents a deviation from current good manufacturing practice (CGMP) standards.
The affected product has been distributed nationwide in the USA as well as internationally to Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, and the United Kingdom. Multiple lot numbers with expiration dates ranging from May 2021 through December 2022 are included in this recall.
Consumers who have purchased affected China-Gel products should stop using them and consult the FDA or their healthcare provider for further guidance.
The recalled product
- Product
- CHINA-GEL (MENTHOL AND CAMOHOR (SYNTHETIC))
- Brand
- CHINA-GEL
- Manufacturer
- China Gel Inc
- Hazard
- bacterial-contamination
- B-cepacia
- CGMP-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot #: a)B122DY
- exp 2021-05
- B183GN
- exp 2021-07
- B262BF
- exp 2021-09
- C002KF
- exp 2022-01
- C030HT
- exp 2022-02
- C094LT
- exp 2022-04
- C275CW
- exp 2022-10
- C338CH
- exp 2022-12
- b) B122DX
- B183GP
- B262BE
- C330BG
UPCs (4)
- 0687806100167
- 687806100082
- 687806100167
- 687806101287
Distribution
Distributed nationwide across the United States.
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