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
Reported: August 23, 2017 Initiated: August 4, 2017 #D-1086-2017
Product Description
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.
Details
- Recalling Firm
- Amgen, Inc.
- Units Affected
- 175,632 vials
- Distribution
- United States including Puerto Rico
- Location
- Thousand Oaks, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Amgen, Inc.. Units affected: 175,632 vials.
Why was this product recalled? ▼
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 23, 2017. Severity: Moderate. Recall number: D-1086-2017.
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