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).
Reported: November 29, 2023 Initiated: October 18, 2023 #D-0117-2024
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
Details
- Recalling Firm
- Exela Pharma Sciences LLC
- Units Affected
- 23,425 vials
- Distribution
- Nationwide
- Location
- Lenoir, NC
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Exela Pharma Sciences LLC. Units affected: 23,425 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: Silicone
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 29, 2023. Severity: Critical. Recall number: D-0117-2024.
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