FDA Drug recall D-0265-2022
5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409…
- FDA Drug
- Class II
- terminated
- Published 2021-12-08
On 2021-12-08 the FDA classified a Class II recall of 5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409… by Pfizer, citing lack of sterility assurance: bag has the potential to leak.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0265-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-30 |
| Published | 2021-12-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pfizer |
| Distribution | US |
Product
5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66
Reason
Lack of sterility assurance: bag has the potential to leak.
Identifiers
| ndc | 0409-7100-68 |
|---|---|
| ndc | 0409-7100-66 |
| ndc | 0409-7100-69 |
| ndc | 0409-7100-67 |
| ndc | 0409-7100-04 |
| ndc | 0409-7100-02 |
| code_info | Lot: 4923608 Exp. 1MAY2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0265-2022%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.