HYDROMORPHONE — Class II drug recall D-0296-2023
Terminated recall by Sentara Infusion Services, reported 2023-02-22, distributed nationwide. Lack of sterility assurance
| Recall number | D-0296-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sentara Infusion Services, Chesapeake, VA, United States |
| Recall initiated | 2022-12-27 |
| Classified | 2023-02-15 |
| Reported by FDA | 2023-02-22 |
| Terminated | 2026-02-20 |
| Distributed | Nationwide (US) |
| Quantity | 37 bags |
| Reason classes | sterility |
| NDC | 00409-2634-50, 00703-0018-01 |
Product
HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 60ML, 100ML, 250ML; pain, Rx only, used with a Curlin pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 00409-2634-50
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-0296-2023. 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.