Recalling firm
Cardinal Health Inc.
Product type
Drug
Status
Ongoing
Report date
2025-08-13
Distribution
Nationwide Within the U.S.
Firm state
OH
Product quantity
6 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change ControlReason for recall
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Product description
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
Code / lot info
Lot: 3617756, Expires: 12/31/2025.
Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.