FDA Drug recall D-1167-2017
HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60…
- FDA Drug
- Class II
- terminated
- Published 2017-09-27
On 2017-09-27 the FDA classified a Class II recall of HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60… by Pfizer, citing lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1167-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-22 |
| Published | 2017-09-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pfizer |
| Distribution | US |
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
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Identifiers
| ndc | 0409-2552-11 |
|---|---|
| ndc | 0409-2552-01 |
| ndc | 0409-3356-11 |
| ndc | 0409-3356-01 |
| ndc | 0409-2540-11 |
| ndc | 0409-2540-01 |
| ndc | 0409-3365-11 |
| ndc | 0409-3365-01 |
| ndc | 0409-3365-10 |
| ndc | 0409-1283-03 |
| ndc | 0409-1283-31 |
| ndc | 0409-1312-03 |
| ndc | 0409-1312-30 |
| ndc | 0409-1304-03 |
| ndc | 0409-1304-31 |
| code_info | Lot: 760853A |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1167-2017%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.