Drug recall D-1173-2017
Product
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
Reason for recall
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Lots and codes
Lot #: a) G290530A, Exp 07/18; b) G290531A, Exp 07/18
Recall details
- Recalling firm
- Amgen, Inc., Thousand Oaks, CA
- Quantity
- 275,380 vials
- Distribution
- U.S.A. Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 13, 2017
- Terminated
- March 29, 2018
Related products
- Procrit – drug information
- NDC 59676-320 Procrit · Epoetin 20000 [iU]/mL · Janssen Products, LP
- NDC 59676-302 Procrit · Epoetin 2000 [iU]/mL · Janssen Products, LP
- NDC 59676-340 Procrit · Epoetin 40000 [iU]/mL · Janssen Products, LP
- NDC 59676-304 Procrit · Epoetin 4000 [iU]/mL · Janssen Products, LP
- NDC 59676-310 Procrit · Epoetin 10000 [iU]/mL · Janssen Products, LP
- NDC 59676-312 Procrit · Epoetin 10000 [iU]/mL · Janssen Products, LP
- NDC 59676-303 Procrit · Epoetin 3000 [iU]/mL · Janssen Products, LP