Class II · Moderate risk
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
What was recalled
Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715. NDC#: 45183-0796-48.
Affected NDCs
45183-0796-48
45183-0989-41
Compare with the code on your package — it is the most precise check available.
Drug: Midazolam
- Recalling firm
- Pharmakon Pharmaceuticals
- Origin
- IN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1566-2014 · 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. 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 Pharmakon Pharmaceuticals
All 2014 recalls
Class II · Moderate risk
Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium…
Lack of Assurance of Sterility
Class II · Moderate risk
Bupivacaine HCI 0.25% in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Midazolam HCl 1mg/mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Vecuronium 1mg/mL in Sterile Water
Lack of Assurance of Sterility
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