Why it was recalled
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
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
Lot numbers, UPCs & expiration codes
Lot #: G290491A, G290491B, Exp. 06/18
Where it was sold
United States including Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1086-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 4, 2017
- FDA report date
- Aug 23, 2017
- Quantity
- 175,632 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amgen, Inc.
Original FDA data
Every field from FDA enforcement report D-1086-2017, exactly as published.
Show all FDA fields
- City
- Thousand Oaks
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 77889
- Address
- 1 Amgen Center Dr
- Code information
- Lot #: G290491A, G290491B, Exp. 06/18
- Postal code
- 91320-1730
- Report date
- Aug 23, 2017
- Product type
- Drugs
- Recall number
- D-1086-2017
- Classification
- Class II
- Recalling firm
- Amgen, Inc.
- Product quantity
- 175,632 vials
- Termination date
- Mar 29, 2018
- Reason for recall
- Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- United States including Puerto Rico
- Recall initiation date
- Aug 4, 2017
- Initial firm notification
- Letter
- Center classification date
- Aug 14, 2017