FDA Drug recall D-1739-2019
Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC 0 52301 35903 5)
- FDA Drug
- Class II
- terminated
- Published 2019-08-21
On 2019-08-21 the FDA classified a Class II recall of Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC 0 52301 35903 5) by Us Pharmaceuticals, citing CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1739-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-11 |
| Published | 2019-08-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Us Pharmaceuticals |
| Distribution | US |
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
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Identifiers
| upc | 052301359035 |
|---|---|
| upc | 052301365043 |
| upc | 052301365326 |
| upc | 052301365166 |
| upc | 052301365128 |
| code_info | Lot # 27H18, EXP 06/2021; 32H18, EXP 06/2021; 42H18, EXP 06/2021; 21J18, EXP 07/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1739-2019%22
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