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.
Recall Number: D-0001-2018
Firm: Pfizer Inc.
Classification: Class III
Status: Terminated
Report Date: 20171011
Initiation Date: 20170712
Termination Date: 20200716
Reason for Recall
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
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.