FDA Drug Class III — Least Serious

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.

Hazard

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

Products

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.
Brand
Pfizer Inc.
UPC
Lot: 51275DD; Exp. 09/01/17

Units Affected

32,276 10 mL vials