D-0001-2018 Class III Terminated

Recalled by Pfizer Inc. — New York, NY

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