FDA Drug recall D-0295-2015
MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only
- FDA Drug
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only by Fresenius Kabi Usa, citing lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0295-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-27 |
| Published | 2014-12-17 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
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
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Identifiers
| ndc | 63323-411-22 |
|---|---|
| ndc | 63323-411-27 |
| ndc | 63323-411-15 |
| ndc | 63323-411-12 |
| ndc | 63323-411-18 |
| ndc | 63323-411-25 |
| ndc | 63323-411-13 |
| ndc | 63323-411-10 |
| ndc | 63323-412-18 |
| ndc | 63323-412-25 |
| ndc | 63323-412-03 |
| ndc | 63323-412-02 |
| ndc | 63323-412-06 |
| ndc | 63323-412-05 |
| ndc | 63323-412-13 |
| ndc | 63323-412-10 |
| code_info | Lot 6003827, Exp. Date 04/2015 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0295-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.