Class III · Low risk
Deferoxamine Mesylate for injection
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Deferoxamine various strengths in normal saline
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Lack of sterility assurance.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Deferoxamine various strengths in normal saline
Drug: Deferoxamine
- Recalling firm
- Walgreens Infusion Services
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0370-2015 · 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 3300 mg/20 mL Sterile Water for Injection syringe
Lack of Sterility Assurance
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.
Other recalls by Walgreens Infusion Services
All 2014 recalls
Class II · Moderate risk
3-in-1 TPN formula daily+overfill Bag
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride/MVI injection 2000 mL Bag
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride injection bag
Lack of Assurance of Sterility
Class II · Moderate risk
Dextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL
Lack of Assurance of Sterility
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.