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
4 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), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Code / lot info
Lot: 3630004, Expires: 10/31/2025.
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.