FDA recall D-1086-2017

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

Reason for recall

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

Distribution

United States including Puerto Rico

Key facts

Status

Terminated

Initiation date

2017-08-04

Report date

2017-08-23

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-1086-2017