Class II
Terminated
Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-310-01), b) box of 25 single use 1 mL vials (NDC 59676-310-02), Rx Only, Manufactured by: Amgen, Inc. Thousand Oaks, CA 91320, Manufactured for: Janssen Products, LP Horsham, PA 19044
- Company
- Amgen, Inc.
- Recall Initiated
- September 13, 2017
- Posted
- September 27, 2017
- Recall Number
- D-1173-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 275,380 vials
- Firm Location
- Thousand Oaks, CA, United States
Reason for Recall
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Distribution
U.S.A. Nationwide
Lot / Code Info
Lot #: a) G290530A, Exp 07/18; b) G290531A, Exp 07/18
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