Drug Enforcement D-093-2013

Presence of Particulate Matter: glass delamination

Status

Terminated

Classification

Class II

Report Date

December 26, 2012

Termination Date

May 7, 2013

Product Information

Product description
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.
Product quantity
20 vials
Reason for recall
Presence of Particulate Matter: glass delamination
Recall initiation reason
Initial firm notification
FAX
Distribution pattern
PA, CA

Location & Firm

Recalling firm
Physicians Total Care, Inc.
Address
12515 E 55th St Ste 100

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-093-2013
Event ID
63841
Recall initiation date
October 4, 2010
Center classification date
December 14, 2012
Code info
Lot #: 44TK, Exp 09/10; 4NQE, Exp 05/11; 4WKN, Exp 11/11; 5KZT, 5RCM, Exp 09/12; 5RZN, Exp 10/12; 5Y8Y, 60E2, Exp 12/12
More code info