HYDROmorphone HCl Injection — Class II drug recall D-1167-2017
Terminated recall by Pfizer Inc., reported 2017-09-27, distributed nationwide. Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manuf
| Recall number | D-1167-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2017-08-22 |
| Classified | 2017-09-15 |
| Reported by FDA | 2017-09-27 |
| Terminated | 2023-02-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | SG |
| Quantity | 115,370 vials |
| Reason classes | sterility |
| NDC | 00409-1283, 00409-1283-03, 00409-1283-31, 00409-1304, 00409-1304-03, 00409-1304-31, 00409-1312, 00409-1312-03, 00409-1312-30, 00409-2540, 00409-2540-01, 00409-2540-11, 00409-2552, 00409-2552-01, 00409-2552-11, 00409-3356, 00409-3356-01, 00409-3356-11, 00409-3365, 00409-3365-01, 00409-3365-10, 00409-3365-11 |
| Lot numbers | 760853A |
Product
HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial)
Reason for recall
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
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-1167-2017. 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.