24 FDA recalls mention Ondansetron. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ondansetron.
Reason Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and…
Reason Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and…
Reason Failed pH Specifications
Reason Lack of sterility assurance
Reason Lack of assurance of sterility.
Reason cGMP deviations: Temperature abuse
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Failed Impurities/Degradation Specifications.
Reason Lack of Processing Controls.
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Reason Microbial Contamination of Non-Sterile Product
Reason CGMP Deviations
Reason Lack of Assurance of Sterility
Reason Failed Impurities/Degradation Specifications; 12 month stability time point
Reason Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Reason Stability data does not support expiry.
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 Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Reason Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot
Reason Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
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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