FDA Drug recall D-1081-2017
Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case
- FDA Drug
- Class II
- terminated
- Published 2017-08-16
On 2017-08-16 the FDA classified a Class II recall of Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case by Hospira Lake Forest, citing presence of Particulate Matter: Silicone oil.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1081-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-26 |
| Published | 2017-08-16 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira Lake Forest |
| Distribution | US |
Product
Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case. Hospira, Inc., Lake Forest, IL 60045 USA, NDC: 0409-2634-50
Reason
Presence of Particulate Matter: Silicone oil
Identifiers
| ndc | 0409-2634-10 |
|---|---|
| ndc | 0409-2634-01 |
| ndc | 0409-2634-25 |
| ndc | 0409-2634-05 |
| ndc | 0409-2634-50 |
| code_info | Lot #: 56260DD, Exp. 01AUG2017 |
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-1081-2017%22
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