Reported Sep 27, 2017 · Terminated
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…
Amgen, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amgen, Inc. · 1 Amgen Center Dr · Thousand Oaks, CA · 91320-1730
Is this the product you have?
- 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 byAmgen, Inc. Thousand Oaks, CA 91320
- Manufactured forJanssen Products, LP Horsham, PA 19044
- Lot codes and dates
Lot #: a) G290530AExp 07/18b) G290531AExp 07/18
- Amount recalled
- 275,380 vials
Where it was sold
- Nationwide
Why it was recalled
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
This product could cause temporary or reversible health problems — stop using it.
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