Recalls / Class II
Class IID-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
- 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 #: a) G290530A, Exp 07/18; b) G290531A, Exp 07/18
Why it was recalled
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
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
- 275,380 vials
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2017-09-13
- FDA classified
- 2017-09-19
- Posted by FDA
- 2017-09-27
- Terminated
- 2018-03-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1173-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.