61 FDA recalls mention Ofloxacin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ofloxacin.
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 Superpotent
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 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 Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
Reason Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or…
Reason Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
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 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 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 Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg
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…
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