Class II · Moderate risk
Rocuronium Bromide Injection
cGMP Deviations: Products were stored outside the drug label specifications.
Rocuronium Bromide 50 mg per 5mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Leaking/damaged syringes.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11
Affected NDC
71449-0004-11
Compare with the code on your package — it is the most precise check available.
Drug: Rocuronium
- Recalling firm
- Denver Solutions, LLC DBA Leiters Health
- Origin
- CO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0374-2025 · 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.
Other Rocuronium recalls
See all
Class II · Moderate risk
rocuronium
Lack of assurance of sterility:
Class II · Moderate risk
rocuronium 50 mg/5 mL
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
rocuronium
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
rocuronium50 mg/5 mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Other recalls by Denver Solutions, LLC DBA Leiters Health
All 2025 recalls
Class II · Moderate risk
Ketamine HCl 50mg per 5mL
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
PHENYLephrine HCl in 0.9% Sodium Chloride
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
dexmedeTOMIDine HCl PF
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
Glycopyrrolate
Lack of Assurance of Sterility: Leaking/damaged syringes.
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