Class II · Moderate risk
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent Drug
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993721
Drug: Midazolam
- Recalling firm
- Cantrell Drug Company
- Origin
- AR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1163-2016 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Midazolam recalls
See all
Class I · High risk
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL
Presence of Particulate Matter: Silicone
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.
Other recalls by Cantrell Drug Company
All 2015 recalls
Class II · Moderate risk
Rocuronium Bromide Injection Solution 5 mL
Lack of Sterility Assurance.
Class II · Moderate risk
Neostigmine Methylsulfate Injection Solution 5 mL
Lack of Sterility Assurance.
Class II · Moderate risk
Adenosine in 0.9% Sodium Chloride 30mL
Lack of Sterility Assurance.
Class II · Moderate risk
Sodium Bicarbonate 8.4% Injection Solution 50 mL
Lack of Sterility Assurance.
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