Procrit (epoetin alfa) injection, 20000 units/mL, 4 mL vial; Mfg By: Amgen Inc., Thousand Oaks, C...
FDA Recall #D-093-2013 — Class II — October 4, 2010
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.
Reason for Recall
Presence of Particulate Matter: glass delamination
Recalling Firm
Physicians Total Care, Inc. — Tulsa, OK
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
20 vials
Distribution
PA, CA
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated