FDA recall D-1173-2017

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

Reason for recall

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

Distribution

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2017-09-13

Report date

2017-09-27

Termination date

2018-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Thousand Oaks, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1173-2017