Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 c...
FDA Recall #D-0117-2024 — Class I — October 18, 2023
Product Description
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 for Recall
Presence of Particulate Matter: Silicone
Recalling Firm
Exela Pharma Sciences LLC — Lenoir, NC
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
23,425 vials
Distribution
Nationwide
Code Information
Lot # 10001088 exp 07/31/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated