FDA Drug recall D-0425-2019
Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mund…
- FDA Drug
- Class II
- terminated
- Published 2019-02-13
On 2019-02-13 the FDA classified a Class II recall of Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mund… by Us Pharmaceuticals, citing GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0425-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-07 |
| Published | 2019-02-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Us Pharmaceuticals |
| Distribution | US |
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
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Identifiers
| code_info | Lot #: 50G17, Exp. 5/2019; 76J17, Exp. 7/2019 |
|---|
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-0425-2019%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.