5% Dextrose Injection — Class II drug recall D-0265-2022
Terminated recall by Pfizer Inc., reported 2021-12-08, distributed nationwide. Lack of sterility assurance: bag has the potential to leak.
| Recall number | D-0265-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2021-11-30 |
| Classified | 2021-12-02 |
| Reported by FDA | 2021-12-08 |
| Terminated | 2023-07-12 |
| Distributed | Nationwide (US) |
| Quantity | 765 bags |
| Reason classes | sterility, packaging |
| NDC | 00409-7100, 00409-7100-02, 00409-7100-04, 00409-7100-66, 00409-7100-67, 00409-7100-68, 00409-7100-69 |
| Lot numbers | 4923608 |
| Expiration dates | 2022-05-01 |
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 for recall
Lack of sterility assurance: bag has the potential to leak.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0265-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.