Why it was recalled
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Product description
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
Lot numbers, UPCs & expiration codes
Lot No.: 3352758, Exp. Date Aug 2021; Lot No.: 3352759, Exp. Date Aug 2021
Where it was sold
Product was distributed nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0650-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 9, 2021
- FDA report date
- Jul 14, 2021
- Quantity
- 88,620 prefilled syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Genentech Inc
Original FDA data
Every field from FDA enforcement report D-0650-2021, exactly as published.
Show all FDA fields
- City
- South San Francisco
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 88100
- Address
- 1 Dna Way
- Code information
- Lot No.: 3352758, Exp. Date Aug 2021; Lot No.: 3352759, Exp. Date Aug 2021
- Postal code
- 94080-4918
- Report date
- Jul 14, 2021
- Product type
- Drugs
- Recall number
- D-0650-2021
- Classification
- Class II
- Recalling firm
- Genentech Inc
- Product quantity
- 88,620 prefilled syringes
- Termination date
- Aug 11, 2022
- Reason for recall
- Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product was distributed nationwide
- Recall initiation date
- Jun 9, 2021
- Initial firm notification
- Letter
- Center classification date
- Jul 6, 2021