27 FDA recalls mention Rocuronium. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Rocuronium.
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Reason Lack of assurance of sterility:
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Reason CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Reason Lack of sterility assurance.
Reason Lack Of Assurance Of Sterility.
Reason Lack of Sterility Assurance.
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Reason Stability data does not support expiry.
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