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.

FDA recall notice · announced October 11, 2017 · Pfizer

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide
Lot/code information: Lot: 51275DD; Exp. 09/01/17
Quantity: 32,276 10 mL vials
Status: Terminated
Products in this recall event:
- 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. (D-0001-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.