Class II · Moderate risk Ongoing
Rocuronium Bromide 50 mg per 5mL
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Rocuronium Bromide Injection Solution 5 mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Sterility Assurance.
What was recalled
Rocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-064-15
- Recalling firm
- Cantrell Drug Company
- NDC code
- 52533-064-15
- Origin
- AR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1079-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Rocuronium recalls
See all
Class II · Moderate risk Terminated
Rocuronium Bromide Injection
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
rocuronium
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
rocuronium 50 mg/5 mL
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
rocuronium
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
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