23 FDA recalls mention Levofloxacin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Levofloxacin.
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: Firm went out of business and could no longer continue stability studies.
Reason Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Reason CGMP Deviations:
Reason cGMP deviations: Temperature abuse
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Reason Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Reason Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Reason Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason Presence of Particulate Matter; contains visible particulate matter identified as mold.
Reason Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and…
Reason Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Reason Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
Reason Lack of sterility assurance.
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 lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is…
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…
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