5 FDA recalls mention Alteplase. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Alteplase.
Reason Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Lack of sterility assurance.
Reason Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
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 because…
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