FDAFDA · Food and drugs·Recall number D-1086-2017
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
Published August 23, 2017 · Recall initiated: August 4, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PROCRIT
- Manufacturer
- Amgen, Inc.
- Distributor
- United States including Puerto Rico
- Lot
- Lot #: G290491A, G290491B, Exp. 06/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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