September 2017 FDA Recall Procrit by Amgen, Inc.
D-1173-2017 - Presence of particulate matter
This Class II drug recall was voluntarily initiated by Amgen, Inc. on September 13, 2017 for the product Procrit. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1173-2017
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
09-13-2017
09-27-2017
275,380 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.
U.S.A. Nationwide
03-29-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-310-01), b) box of 25 single use 1 mL vials (NDC 59676-310-02), Rx Only, Manufactured by: Amgen, Inc. Thousand Oaks, CA 91320, Manufactured for: Janssen Products, LP Horsham, PA 19044
Batch or Lot Expiration Information
Lot# : a) G290530A, Exp 07/18; b) G290531A, Exp 07/18
