Class II · Moderate risk Terminated
Deferoxamine 3300 mg/20 mL Sterile Water for Injection syringe
Reason Lack of Sterility Assurance
Deferoxamine Mesylate for injection
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
What was recalled
Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcutaneous Use, Rx Only, Hospira, Inc., Lake Forest IL USA, NDC 0406-2336-10.
- Recalling firm
- Pfizer Inc.
- NDC code
- 0406-2336-10
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0001-2018
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.
Other Deferoxamine recalls
See all
Class II · Moderate risk Terminated
Deferoxamine 4 grams/NS 101 mL Cassette
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
Deferoxamine 2 grams/51 mL NS cassette
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
DEFEROXAMINE MESYLATE 3gm / NS 240mL Accuflo
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Class III · Low risk Terminated
Deferoxamine various strengths in normal saline
Reason Lack of sterility assurance.
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