FDA Drug recall D-0215-2019
5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20
- FDA Drug
- Class II
- terminated
- Published 2018-11-14
On 2018-11-14 the FDA classified a Class II recall of 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20 by Icu Medical, citing lack of Assurance of Sterility; bags have the potential to leak.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0215-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-08 |
| Published | 2018-11-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045
Reason
Lack of Assurance of Sterility; bags have the potential to leak
Identifiers
| code_info | Lots: a) 84-017-JT Exp. December 01, 2019; b) 84-012-JT Exp. June 01, 2019 |
|---|
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-0215-2019%22
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