FDAClass IIIOctober 11, 2017

Deferoxamine Mesylate for injection recall: Impurity Out of Spec

Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcutaneous Use, Rx Only, Hospira…

Why was Deferoxamine Mesylate for injection recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 51275DD; Exp. 09/01/17

Product
Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcutaneous Use, Rx Only, Hospira…
Recalling firm
Pfizer Inc.
Quantity
32,276 10 mL vials
Distribution
Nationwide
Recall date
October 11, 2017
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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