Drug 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.
D-0001-2018
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 77731
- Status
- Terminated
- Classification
- Class III
- Quantity
- 32,276 10 mL vials
- Official record key
drug-enforcement:D-0001-2018
Official wording
Reason: CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Code information: Lot: 51275DD; Exp. 09/01/17
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations