PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 27, 2017 Initiated: September 13, 2017 #D-1173-2017

Product Description

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

Reason for Recall

Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.

Details

Recalling Firm
Amgen, Inc.
Units Affected
275,380 vials
Distribution
U.S.A. Nationwide
Location
Thousand Oaks, CA

Frequently Asked Questions

What product was recalled?
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. Recalled by Amgen, Inc.. Units affected: 275,380 vials.
Why was this product recalled?
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 27, 2017. Severity: Moderate. Recall number: D-1173-2017.