HYDROmorphone HCl in Sodium Chloride 0 — Class II drug recall D-0428-2018
Terminated recall by Pharmedium Services, LLC, reported 2018-02-28, distributed nationwide. Lack of sterility assurance.
| Recall number | D-0428-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmedium Services, LLC, Lake Forest, IL, United States |
| Recall initiated | 2017-12-27 |
| Classified | 2018-02-20 |
| Reported by FDA | 2018-02-28 |
| Terminated | 2020-05-07 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
Product
HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging.
Reason for recall
Lack of sterility assurance.
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-0428-2018. 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.