FDA recall D-0001-2018

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 for recall

CGMP Deviations: Firm failed to control impurity for color change at the API stage.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-07-12

Report date

2017-10-11

Termination date

2020-07-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0001-2018