FDAFDA · Food and drugs·Recall number 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 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).
Published November 29, 2023 · Recall initiated: October 18, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Silicone
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Exela Pharma Sciences LLC
- Distributor
- Nationwide
- Lot
- Lot # 10001088 exp 07/31/2024
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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