Class II · Moderate risk
Rocuronium Bromide 50 mg per 5mL
Lack of Assurance of Sterility: Leaking/damaged syringes.
Rocuronium Bromide Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations: Products were stored outside the drug label specifications.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10
Affected NDC
55150-0226-10
Compare with the code on your package — it is the most precise check available.
Drug: Rocuronium
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Rocuronium Bromide NDC 55150-0226 |
100 mg/10mL | Injection, Solution Intravenous |
Eugia US LLC | Rx |
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- NDC code
- 55150-226-10
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0371-2024 · 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 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 Mckesson Medical-Surgical Inc. Corporate Office
All 2024 recalls
Class II · Moderate risk
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Class II · Moderate risk
Evenity
CGMP Deviations; potential temperature excursions due to transit delays
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