FDA recall D-093-2013

Physicians Total Care, Inc. · Class II · drug

Product

Procrit (epoetin alfa) injection, 20000 units/mL, 4 mL vial; Mfg By: Amgen Inc., Thousand Oaks, CA 91320; Dist. By: Physicians Total Care, Tulsa, OK 74146; NDC 54868-5673-1.

Reason for recall

Presence of Particulate Matter: glass delamination

Distribution

PA, CA

Key facts

Status: Terminated
Initiation date: 2010-10-04
Report date: 2012-12-26
Termination date: 2013-05-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tulsa, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-093-2013