Deferoxamine Mesylate for injection recalled over manufacturing violations

Recall date

July 12, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pfizer Inc. recalls Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcuta…

Recall number

D-0001-2018

FDA classification

Class III

Brand / firm

Pfizer Inc.

Sold / distributed

Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.