FDA Drug recall D-0152-2018
Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius…
- FDA Drug
- Class I
- terminated
- Published 2018-01-10
On 2018-01-10 the FDA classified a Class I recall of Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius… by Fresenius Kabi Usa, citing labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0152-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-10-27 |
| Published | 2018-01-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20
Reason
Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL
Identifiers
| ndc | 76045-211-00 |
|---|---|
| ndc | 76045-211-20 |
| ndc | 76045-001-00 |
| ndc | 76045-001-20 |
| ndc | 76045-002-00 |
| ndc | 76045-002-10 |
| ndc | 76045-003-00 |
| ndc | 76045-003-20 |
| code_info | Lot: 6400048 |
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-0152-2018%22
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