August 2017 FDA Recall Procrit by Amgen, Inc.
D-1086-2017 - Presence of particulate matter
This Class II drug recall was voluntarily initiated by Amgen, Inc. on August 4, 2017 for the product Procrit. The FDA reported the reason for recall as presence of particulate matter. The product was distributed in United States including Puerto Rico and the recall is currently terminated.
Recall Number: D-1086-2017
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
08-04-2017
08-23-2017
175,632 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Amgen, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
United States including Puerto Rico
03-29-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044, NDC 59676-340-01
Batch or Lot Expiration Information
Lot# : G290491A, G290491B, Exp. 06/18
