AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for: Onyx Pharmaceuticals, Inc., Thousand Oaks, CA 91320-1799, U.S.A., NDC 76075-102-01

FDA recall notice · announced December 28, 2016 · Amgen

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

The product

AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for: Onyx Pharmaceuticals, Inc., Thousand Oaks, CA 91320-1799, U.S.A., NDC 76075-102-01

Reason for recall

Lack of Assurance of Sterility: Potential cracks in glass vials

Notes

Distribution: United States and Puerto Rico No foreign distribution.
Lot/code information: Lot #1071559, 1071629; Exp. 05/18
Quantity: 11,434 vials
Status: Terminated
Products in this recall event:
- AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for: Onyx Pharmaceuticals, Inc., Thousand Oaks, CA 91320- (D-0226-2017)

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