FDA Drug recall D-0001-2018
Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial
- FDA Drug
- Class III
- terminated
- Published 2017-10-11
On 2017-10-11 the FDA classified a Class III recall of Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial by Pfizer, citing CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0001-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-07-12 |
| Published | 2017-10-11 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pfizer |
| Distribution | US |
Product
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.
Reason
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Identifiers
| code_info | Lot: 51275DD; Exp. 09/01/17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0001-2018%22
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