Class II · Moderate risk
Rocuronium Bromide 50 mg per 5mL
Lack of Assurance of Sterility: Leaking/damaged syringes.
ROCuronium Bromide 10 mg per mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack Of Assurance Of Sterility.
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 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-850-09
Affected NDC
70004-0850-09
Compare with the code on your package — it is the most precise check available.
Drug: Rocuronium
- Recalling firm
- SCA Pharmaceuticals, LLC
- NDC code
- 70004-850-09
- Origin
- AR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0068-2018 · 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 SCA Pharmaceuticals, LLC
All 2017 recalls
Class II · Moderate risk
VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
SUCcinylcholine Chloride 100 mg/5mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
SUCcinylcholine Chloride 200 mg/10mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Citrate 4% 3 mL
Lack of Assurance of Sterility
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