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
Product summary
- 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
Particulate Matter