Soothe & Cool Protect Moisture Guard Skin Protectant — Class II drug recall D-0425-2019
Terminated recall by US Pharmaceuticals Inc., reported 2019-02-13, distributed nationwide. GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sam
| Recall number | D-0425-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | US Pharmaceuticals Inc., Belleville, NJ, United States |
| Recall initiated | 2018-12-07 |
| Classified | 2019-02-04 |
| Reported by FDA | 2019-02-13 |
| Terminated | 2023-11-06 |
| Distributed | Nationwide (US) |
| Quantity | 19,752 units |
| Reason classes | microbial contamination, cgmp, specification failure |
| NDC | 53329-0303-22 |
| Lot numbers | 50G17, 76J17 |
| Expiration dates | 2019-05, 2019-07 |
Product
Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22
Reason for recall
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
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-0425-2019. 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.