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Recall Observatory FDA recall evidence

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.

D-093-2013

October 04, 2010

Class II

Product summary

Firm
Physicians Total Care, Inc.
Event
Event 63841
Status
Terminated
Classification
Class II
Quantity
20 vials
Official record key
drug-enforcement:D-093-2013

Official wording

Reason: Presence of Particulate Matter: glass delamination

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

Distribution pattern: PA, CA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter