13 FDA recalls mention Gatifloxacin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Gatifloxacin.
Reason Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the…
Reason Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug…
Reason Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug…
Reason Labeling: Incorrect or missing package insert.
Reason Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Reason Labeling: Missing label; Product complaints reported missing bottle label.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Presence of precipitate
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
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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