Class II · Moderate risk
Deferoxamine 3300 mg/20 mL Sterile Water for Injection syringe
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.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
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.
Affected NDC
0406-2336-10
Compare with the code on your package — it is the most precise check available.
Drug: Deferoxamine
- Recalling firm
- Pfizer Inc.
- NDC code
- 0406-2336-10
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0001-2018 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Deferoxamine recalls
See all
Class II · Moderate risk
Deferoxamine 4 grams/NS 101 mL Cassette
Lack of Sterility Assurance
Class II · Moderate risk
Deferoxamine 2 grams/51 mL NS cassette
Lack of Sterility Assurance.
Class II · Moderate risk
DEFEROXAMINE MESYLATE 3gm / NS 240mL Accuflo
Lack of Assurance of Sterility: Sterility of product is not assured.
Class III · Low risk
Deferoxamine various strengths in normal saline
Lack of sterility assurance.
Other recalls by Pfizer Inc.
All 2017 recalls
Class II · Moderate risk
Dopamine HCl Inj.
Lack of Assurance of Sterility
Class II · Moderate risk
Vial Label: 8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Vial Label: Epinephrine Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Levoxyl (levothyroxine sodium tablets, USP)
Subpotent drug
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