Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Sterility Assurance.
Deferoxamine 2 grams/51 mL NS cassette, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
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 Assurance of Sterility: Sterility of product is not assured.
Reason Lack of sterility assurance.
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