Why it was recalled
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: a) G290530A, Exp 07/18; b) G290531A, Exp 07/18
Where it was sold
U.S.A. Nationwide
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-1173-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 13, 2017
- FDA report date
- Sep 27, 2017
- Quantity
- 275,380 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amgen, Inc.
Original FDA data
Every field from FDA enforcement report D-1173-2017, exactly as published.
Show all FDA fields
- City
- Thousand Oaks
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 78110
- Address
- 1 Amgen Center Dr
- Code information
- Lot #: a) G290530A, Exp 07/18; b) G290531A, Exp 07/18
- Postal code
- 91320-1730
- Report date
- Sep 27, 2017
- Product type
- Drugs
- Recall number
- D-1173-2017
- Classification
- Class II
- Recalling firm
- Amgen, Inc.
- Product quantity
- 275,380 vials
- Termination date
- Mar 29, 2018
- Reason for recall
- Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Sep 13, 2017
- Initial firm notification
- Letter
- Center classification date
- Sep 19, 2017