CLASS II Drug recall · Reported 26 Dec 2012 · FDA Enforcement Report

Procrit (epoetin alfa) injection/mL vial recalled

Physicians Total Care is recalling Procrit (epoetin alfa) injection/mL vial, distributed in California, Pennsylvania. The recall was initiated on 4 Oct 2010 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 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
Quantity recalled20 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-093-2013
FDA event ID
63841
Recalling firm
Physicians Total Care, Tulsa, OK
Classification
Class II
Status
Terminated
Recall initiated
4 Oct 2010
FDA classified
14 Dec 2012
Reported
26 Dec 2012
Type
Voluntary: Firm initiated
Customers notified by
FAX
Reason category
Particulate Matter

Timeline

4 Oct 2010Recall initiated by company
14 Dec 2012Classified by FDA+802 days
26 Dec 2012Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of Particulate Matter: glass delamination

Product as listed by the FDA

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.

Where it was distributed

PA, CA

CaliforniaPennsylvania

Questions about this recall

Why was it recalled?

Presence of Particulate Matter: glass delamination

Which lots are affected?

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

Where was it sold?

PA, CA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Physicians Total Care

All 21