D-0001-2018 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 11, 2017
- Initiation Date
- July 12, 2017
- Termination Date
- July 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32,276 10 mL vials
Product Description
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 for Recall
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Distribution Pattern
Nationwide
Code Information
Lot: 51275DD; Exp. 09/01/17