FDA Drug recall D-0117-2024
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous…
- FDA Drug
- Class I
- ongoing
- Published 2023-11-29
On 2023-11-29 the FDA classified a Class I recall of Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous… by Exela Pharma Sciences, citing presence of Particulate Matter: Silicone.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0117-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-10-18 |
| Published | 2023-11-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Exela Pharma Sciences |
| Distribution | US |
Product
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion Only Preservative Free, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial NDC 51754-2131-1; Carton NDC 51754-2131-4).
Reason
Presence of Particulate Matter: Silicone
Identifiers
| code_info | Lot # 10001088 exp 07/31/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0117-2024%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.