FDAClass IIAugust 23, 2017

Procrit Epoetin Alfa 40 recall: Particulate Matter

Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks…

Why was Procrit Epoetin Alfa 40 recalled?

Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.

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 #: G290491A, G290491B, Exp. 06/18

Product
Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks…
Recalling firm
Amgen, Inc.
Quantity
175,632 vials
Distribution
United States including Puerto Rico
Recall date
August 23, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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