Recalls of antibiotics used to treat bacterial infections.
192 recalls in this category, newest first.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Reason CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Reason Failed Impurity/Degradation Specifications
Reason Failed Impurity/Degradation Specifications
Reason Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS…
Reason Sub-Potent Drug: Out of specification test results for potency (below specification).
Reason CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Reason CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Reason Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
Reason Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Reason Failed dissolution specifications
Reason Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
Reason CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Reason CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Reason Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Reason Presence of Foreign substance: identified as a dead ant.
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 Product: assay results for Amoxicillin were below the specification limits.
Reason Lack of sterility assurance.
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