Drug 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).
D-0117-2024
Product summary
- Event
- Event 93265
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 23,425 vials
- Official record key
drug-enforcement:D-0117-2024
Official wording
Reason: Presence of Particulate Matter: Silicone
Code information: Lot # 10001088 exp 07/31/2024
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter