Kool Comfort Cooling Pain Relief — Class II drug recall D-1739-2019
Terminated recall by US Pharmaceuticals Inc., reported 2019-08-21, distributed nationwide. CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the
| Recall number | D-1739-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | US Pharmaceuticals Inc., Belleville, NJ, United States |
| Recall initiated | 2019-07-11 |
| Classified | 2019-08-13 |
| Reported by FDA | 2019-08-21 |
| Terminated | 2020-06-25 |
| Distributed | Nationwide (US) |
| Quantity | 2,192 cases |
| Reason classes | microbial contamination, cgmp, specification failure |
| UPC / GTIN / UDI-DI | 00052301359035, 00052301365043, 00052301365128, 00052301365166, 00052301365326 |
| Lot numbers | 21J18, 27H18, 32H18, 42H18 |
| Expiration dates | 2021-06, 2021-07 |
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 Laboratories, Inc. 304 Dee Cee Rd., White House, TN 37188.
Reason for recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1739-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.