FDA Drug recall D-1738-2019
Cool Hot Ice Analgesic Gel, 8 oz (227 g) Distributed by: Unipack Inc
- FDA Drug
- Class II
- terminated
- Published 2019-08-21
On 2019-08-21 the FDA classified a Class II recall of Cool Hot Ice Analgesic Gel, 8 oz (227 g) Distributed by: Unipack Inc 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-1738-2019 |
| 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
Cool Hot Ice Analgesic Gel, 8 oz (227 g) Distributed by: Unipack Inc. Pittsburg, PA 15239, USA. UPC 7 51393 00608 6
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 | 751393006086 |
|---|---|
| code_info | Lot # 14L18, EXP 09/2020 |
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-1738-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.