8 FDA recalls mention Gemcitabine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Gemcitabine.
Reason Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Reason Lack of Assurance of Sterility
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Lack of Assurance of Sterility
Reason Presence of Particulate Matter
Reason Presence of Particulate Matter
Reason Presence of Particulate Matter
Reason Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
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