Medline Remedy Essential Barrier Skin Protectant Ointment — Class II drug recall D-0427-2019
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-0427-2019 |
|---|---|
| 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 | 7,020 units |
| Reason classes | microbial contamination, cgmp, specification failure |
| NDC | 53329-0302-14, 53329-0302-41 |
| Expiration dates | 2019-05 |
Product
Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.
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-0427-2019. 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.