China-Gel Topical Pain Reliever Recalled for Manufacturing Facility Contamination
China-Gel Inc is recalling China-Gel White topical pain reliever products due to potential contamination with Burkholderia cepacia found at the manufacturing facility. The recall affects multiple package sizes distributed nationwide and internationally.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall involving a high-risk pathogen (Burkholderia cepacia) found at the manufacturing facility. Although no illnesses or injuries are reported in the source text, the presence of a pathogenic organism with potential for serious infection in a topical product qualifies as a high-risk contamination recall under the rubric.
Plain-English summary
China-Gel Inc is recalling all lots of China-Gel White (containing 3% Camphor and 5% Menthol), a topical pain reliever. The recall was initiated because the product was manufactured in a facility where contamination with Burkholderia cepacia was detected in other products.
The affected product is available in six package sizes: 2 oz tube, 4 oz jar, 6 oz tube, 8 oz jar, 16 oz bottle with pump, and 120 oz gallon. A total of 40,289 units are involved in the recall, with specific lot numbers and expiration dates ranging from April 2021 through October 2022 listed for each package configuration.
The product has been distributed nationwide in the USA as well as to Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, and the United Kingdom. Consumers who have purchased this product should stop using it and consult with their healthcare provider or poison control if they have health concerns. Healthcare providers should be aware of this recall when treating patients using this product.
The recalled product
- Product
- CHINA-GEL (MENTHOL AND CAMOHOR (SYNTHETIC))
- Brand
- CHINA-GEL
- Manufacturer
- China Gel Inc
- Affected units
- 40,289
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 (19)
- Lot #: a)B100JS
- Exp 04/2021
- B183GQ
- EXP 07-2021
- B255KZ
- EXP 09-2021
- C030HS
- EXP 02-2022
- C100AH
- EXP 04-2022
- C247JF
- EXP 09-2022
- b)B100JS
- c)B100JS
- d)B100JS
- e)B100JS
- f)B100JS
- EXP 06-2022
- EXP 10-2022
UPCs (6)
- 0687806200164
- 687806200041
- 687806200065
- 687806200089
- 687806200164
- 687806201284
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by China Gel Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same brand · CHINA-GEL
- HighChina-Gel Topical Pain Reliever Recall Due to Manufacturing Contamination
FDA (Drugs) · 2021-09-08
Same manufacturer · China Gel Inc
See all →- HighTopical Pain Relief AULIEF Recalled for Facility Contamination Risk
FDA (Drugs) · 2021-09-08
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