US Pharmaceuticals Recalls Kool Comfort Cooling Pain Relief Due to Water Quality Issues
US Pharmaceuticals is recalling Kool Comfort Cooling Pain Relief because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a manufacturing deviation (water quality) without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
US Pharmaceuticals Inc. is recalling Kool Comfort Cooling Pain Relief, 5% Menthol, in various package sizes. The recall is due to Current Good Manufacturing Practice (CGMP) deviations where the purified water used in the manufacturing process produced out-of-specification results for either total microbial count or total organic carbon.
The affected product was distributed nationwide in the USA. The recall covers 2,192 cases with lot numbers 27H18, 32H18, 42H18, and 21J18, all with expiration dates of June or July 2021.
Consumers should stop using the product and return it to the place of purchase for a refund or contact the recalling firm for instructions.
The recalled product
- Product
- Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC 0 52301 35903 5); b) 4 OZ/ 113 g (UPC 0 52301 36504 3); c) 32 OZ/ 907 g (UPC 0 52301 36532 6); d) 16 OZ/ 454 g (UPC 0 52301 36516 6); e) 128 OZ/ 3629 g (UPC 0 52301 36512 8) Manufactured for: Dee Cee…
- Manufacturer
- US Pharmaceuticals Inc.
- Category
- Drug — Topical Analgesic
- Affected units
- 2,192
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 (6)
- Lot # 27H18
- EXP 06/2021
- 32H18
- 42H18
- 21J18
- EXP 07/2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by US Pharmaceuticals 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.
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