Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Lack of sterility assurance.
Deferoxamine various strengths in normal saline
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 CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Reason Lack of Sterility Assurance
Reason Lack of Sterility Assurance
Reason Lack of Sterility Assurance.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
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