CLASS III Drug recall · Reported 11 Oct 2017 · FDA Enforcement Report
Deferoxamine Mesylate for injection, USP, Single-use Vial recalled
Pfizer is recalling Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, distributed nationwide in the US. The recall was initiated on 12 Jul 2017 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0001-2018
- FDA event ID
- 77731
- Recalling firm
- Pfizer, New York, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Jul 2017
- FDA classified
- 3 Oct 2017
- Reported
- 11 Oct 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Jul 2017 | Recall initiated by company | |
| 3 Oct 2017 | Classified by FDA | +83 days |
| 11 Oct 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Which lots are affected?
Lot: 51275DD; Exp. 09/01/17
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | Dopamine HCl Inj., USP, 200 mg/ (40 mg/mL) Single-dose recalledDopamine Hydrochloride | Pfizer | Sterility | Nationwide |
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| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), 50 mcg recalled by PfizerLevoxyl | Pfizer | Potency & Assay | NY |
| Drug | CLASS II | Bicillin L-A (penicillin G benzathine injectable recalled by PfizerBicillin L-a | Pfizer | Particulate Matter | Nationwide |
Other Deferoxamine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Deferoxamine 3300 mg/ Sterile Water for Injection syringe recalled | Baptist Health Medical Towers Pharmacy and Infusion Services | Sterility | AR |