Recalls / Class II
Class IID-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
- Brand name
- Procrit
- Generic name
- Erythropoietin
- Active ingredient
- Epoetin
- Route
- Intravenous, Subcutaneous
- NDCs
- 59676-302, 59676-303, 59676-304, 59676-310, 59676-340, 59676-312, 59676-320
- FDA application
- BLA103234
- Affected lot / code info
- Lot #: G290491A, G290491B, Exp. 06/18
Why it was recalled
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Recalling firm
- Firm
- Amgen, Inc.
- Manufacturer
- Janssen Products, LP
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Amgen Center Dr, N/A, Thousand Oaks, California 91320-1730
Distribution
- Quantity
- 175,632 vials
- Distribution pattern
- United States including Puerto Rico
Timeline
- Recall initiated
- 2017-08-04
- FDA classified
- 2017-08-14
- Posted by FDA
- 2017-08-23
- Terminated
- 2018-03-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1086-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.