RecallDepth
Class II Terminated

Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044, NDC 59676-340-01

Company
Amgen, Inc.
Recall Initiated
August 4, 2017
Posted
August 23, 2017
Recall Number
D-1086-2017
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
175,632 vials
Firm Location
Thousand Oaks, CA, United States

Reason for Recall

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

Distribution

United States including Puerto Rico

Lot / Code Info

Lot #: G290491A, G290491B, Exp. 06/18

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