FDA Drug recall D-0597-2018
Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation
- FDA Drug
- Class I
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class I recall of Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation by Pfizer, citing non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0597-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-02-07 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pfizer |
| Distribution | US |
Product
Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01
Reason
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Identifiers
| ndc | 0409-2634-10 |
|---|---|
| ndc | 0409-2634-01 |
| ndc | 0409-2634-25 |
| ndc | 0409-2634-05 |
| ndc | 0409-2634-50 |
| code_info | Lot 71330DD EXP. 11/1/2018. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0597-2018%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.