21 FDA recalls mention Polymyxin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Polymyxin.
Reason CGMP Deviations; deficiencies observed during FDA inspection
Reason CGMP Deviations; deficiencies observed during FDA inspection
Reason CGMP Deviations; deficiencies observed during FDA inspection
Reason CGMP Deviations; deficiencies observed during FDA inspection
Reason CGMP Deviations; deficiencies observed during FDA inspection
Reason CGMP Deviations
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason CGMP Deviations:
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: Temperature abuse
Reason Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Reason Labeling: Incorrect or missing package insert.
Reason CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Reason CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Reason Lack of Assurance of Sterility
Reason Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Reason Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Reason Failed Stability Specifications: Unable to meet shelf life expiry.
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