FDA Drug recall D-0384-2021
Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., La…
- FDA Drug
- Class II
- terminated
- Published 2021-05-26
On 2021-05-26 the FDA classified a Class II recall of Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., La… by Pfizer, citing presence of Particulate Matter: particulate matter identified as an insect in one vial.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0384-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-03 |
| Published | 2021-05-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pfizer |
| Distribution | US |
Product
Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, NDC Carton: 0409-4887-99; NDC Vial: 0409-4887-25
Reason
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Identifiers
| ndc | 0409-4887-25 |
|---|---|
| ndc | 0409-4887-99 |
| ndc | 0409-4887-31 |
| ndc | 0409-4887-05 |
| ndc | 0409-4887-17 |
| ndc | 0409-4887-10 |
| ndc | 0409-4887-32 |
| ndc | 0409-4887-34 |
| ndc | 0409-4887-23 |
| ndc | 0409-4887-20 |
| ndc | 0409-4887-24 |
| ndc | 0409-4887-50 |
| code_info | Lot DN9185 |
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-0384-2021%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.