MIDAZOLAM INJECTION — Class II drug recall D-0456-2017
Terminated recall by Fresenius Kabi USA, LLC, reported 2017-02-08, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0456-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2016-12-16 |
| Classified | 2017-02-02 |
| Reported by FDA | 2017-02-08 |
| Terminated | 2018-06-22 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 63323-0411, 63323-0411-10, 63323-0411-12, 63323-0411-13, 63323-0411-15, 63323-0411-18, 63323-0411-22, 63323-0411-25, 63323-0411-27, 63323-0412, 63323-0412-02, 63323-0412-03, 63323-0412-05, 63323-0412-06, 63323-0412-10, 63323-0412-13, 63323-0412-18, 63323-0412-25 |
| Lot numbers | 6007327, 6007329 |
| Expiration dates | 2017-01 |
Product
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05
Reason for recall
Failed Impurities/Degradation Specifications
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-0456-2017. 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.