28 FDA recalls mention Neomycin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Neomycin.
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; 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:
Reason CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin…
Reason CGMP Deviations: products were stored outside the drug label specifications.
Reason cGMP deviations: Temperature abuse
Reason Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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 Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of sterility assurance.
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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the…
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