Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
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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