Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS…
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
147 FDA recalls mention Vancomycin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Vancomycin.
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason cGMP violations
Reason Superpotent Drug: Due to overfilling of drug powder
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Reason Lack of Assurance of Sterility
Reason Labeling: Not Elsewhere Classified
Reason Labeling: Not Elsewhere Classified
Reason Lack of Assurance of Sterility
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. Validation data for decontamination cycles is lacking.
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
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.
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