FDA-Drug2023-11-29Class I

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).

Exela Pharma Sciences LLC
Hazard

Presence of Particulate Matter: Silicone

Sold states
Nationwide
Affected count
23,425 vials
Manufactured in
1245 Blowing Rock Blvd, N/A, Lenoir, NC, United States
Products
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).

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0117-2024

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