October 2010 FDA Recall Drug by Physicians Total Care, Inc.
D-093-2013 - Presence of Particulate Matter

This Class II drug recall was voluntarily initiated by Physicians Total Care, Inc. on October 4, 2010 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed in PA, CA and the recall is currently terminated.

Recall Number: D-093-2013

Reason for Recall
Presence of Particulate Matter: glass delamination
Initiated
10-04-2010
Reported
12-26-2012
Quantity
20 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63841
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Physicians Total Care, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
FAX
Distribution Pattern About Distribution Pattern
General area of initial distribution.
PA, CA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-07-2013
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration 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