MIDAZOLAM HYDROCHLORIDE INJECTION — Class II drug recall D-0295-2015
Terminated recall by Fresenius Kabi USA, LLC, reported 2014-12-17, distributed nationwide. Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
| Recall number | D-0295-2015 |
|---|---|
| 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 | 2012-09-27 |
| Classified | 2014-12-10 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2014-12-12 |
| Distributed | Nationwide (US) |
| Quantity | 101,200 vials |
| Reason classes | foreign material, sterility, device malfunction |
| 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 | 6003827 |
| Expiration dates | 2015-04 |
Product
MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25.
Reason for recall
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
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-0295-2015. 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.