Class II · Moderate risk
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: Silicone
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What 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).
Affected NDCs
51754-2131-01
51754-2131-04
Compare with the code on your package — it is the most precise check available.
Drug: Midazolam
- Recalling firm
- Exela Pharma Sciences LLC
- NDC code
- 51754-2131-1
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0117-2024 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other Midazolam recalls
See all
Class II · Moderate risk
midazolam in dextrose 5%
Lack of assurance of sterility:
Class II · Moderate risk
midazolam in dextrose 5%
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
Midazolam Injection
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Midazolam Injection
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Other recalls by Exela Pharma Sciences LLC
All 2023 recalls
Class II · Moderate risk
4.2% Sodium Bicarbonate Injection
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Class II · Moderate risk
8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility
Class I · High risk
ELCYS (cysteine hydrochloride injection)
Presence of Particulate Matter: Silicone
Class I · High risk
8.4% Sodium Bicarbonate Injection
Presence of Particulate Matter: Silicone
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