Drug recall D-1086-2017
Product
Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044, NDC 59676-340-01
Reason for recall
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Lots and codes
Lot #: G290491A, G290491B, Exp. 06/18
Recall details
- Recalling firm
- Amgen, Inc., Thousand Oaks, CA
- Quantity
- 175,632 vials
- Distribution
- United States including Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 4, 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