June 2021 FDA Recall Xolair by Genentech Inc
D-0650-2021 - Failed Stability Specifications
This Class II drug recall was voluntarily initiated by Genentech Inc on June 9, 2021 for the product Xolair. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0650-2021
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
06-09-2021
07-14-2021
88,620 prefilled syringes
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Genentech Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed nationwide
08-11-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled Syringe. Product of France, Manufactured by: Genentech, Inc. A Member of the Roche Group, South San Francisco, CA 9480-4990. NDC: 50242-215-01
Batch or Lot Expiration Information
Lot# Lot No.: 3352758, Exp. Date Aug 2021; Lot No.: 3352759, Exp. Date Aug 2021
