Class II · Moderate risk
Rocuronium Bromide 50 mg per 5mL
Lack of Assurance of Sterility: Leaking/damaged syringes.
ROcuronium Bromide 50 mg/5 mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-090-05
Affected NDC
71546-0090-05
Compare with the code on your package — it is the most precise check available.
Drug: Rocuronium
- Recalling firm
- New England Life Care, Inc. dba Advanced Compounding Solutions
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0928-2023 · 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 Bromide Injection
cGMP Deviations: Products were stored outside the drug label specifications.
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
Other recalls by New England Life Care, Inc. dba Advanced Compounding Solutions
All 2023 recalls
Class II · Moderate risk
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class II · Moderate risk
PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class II · Moderate risk
SUCCINYLcholine Chloride 200 mg/10mL
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class III · Low risk
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag
Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
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