Class II
Terminated
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
- Company
- Genentech, Inc.
- Recall Initiated
- June 9, 2021
- Posted
- July 14, 2021
- Recall Number
- D-0650-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 88,620 prefilled syringes
- Firm Location
- South San Francisco, CA, United States
Reason for Recall
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Distribution
Product was distributed nationwide
Lot / Code Info
Lot No.: 3352758, Exp. Date Aug 2021; Lot No.: 3352759, Exp. Date Aug 2021
More recalls by Genentech, Inc.
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC...
Jun 5, 2024 · Class II
Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-...
Nov 9, 2022 · Class III
Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution...
May 5, 2021 · Class III
Other recent Class II Drug recalls
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, L...
Wizcure Pharmaa Private Limited
· Mar 4, 2026
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: Av...
Avkare
· Mar 4, 2026
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX I...
Agebox
· Mar 4, 2026
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPL...
Leo Pharma Inc
· Mar 4, 2026
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per...
Pro Numb Tattoo Numbing Spray Llc
· Feb 18, 2026