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 Prod

FDA recall notice · announced September 27, 2017 · Amgen

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.

Notes

Distribution: U.S.A. Nationwide
Lot/code information: Lot #: a) G290530A, Exp 07/18; b) G290531A, Exp 07/18
Quantity: 275,380 vials
Status: Terminated
Products in this recall event:
- 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. (D-1173-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.