Why it was recalled
Failed Impurities/Degradation Specifications.
Product description
Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-0911-05) Rx Only, Manufactured by: The Ritedose Corporation, Columbia, SC 29203, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936.
Lot numbers, UPCs & expiration codes
Lot #:a) and b) 20E21, 20E22, 20E53, 20E54, 20E95, 20E96, 20ED1, 20ED2, 20ED3, 20EK1 Exp. Date 4/2023; 20F27, 20F28, 20F66, 20F67,20FH6, Exp. Date 05/2023; 20G47, 20G48, 20G49, 20G57, 20GB8, 20GE5, 20GE6, Exp. Date 06/2023; 20M41, 20M42, 20M56, 20M66, 20M67, 20MA4, Exp. Date 07/2023; 20S20, 20S22, 20S44, 20S94, Exp. Date 10/2023; 20SA6, 20SA7, 20SE0, Exp. Date 10/2023, 20TE2, 20TG5, Exp. Date 11/2023.
Where it was sold
Nationwide within the United States
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-0982-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 10, 2022
- FDA report date
- Jun 15, 2022
- Quantity
- 1,187,092 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Pharmaceuticals Corporation
Original FDA data
Every field from FDA enforcement report D-0982-2022, exactly as published.
Show all FDA fields
- City
- East Hanover
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90176
- Address
- 1 Health Plz
- Code information
- Lot #:a) and b) 20E21, 20E22, 20E53, 20E54, 20E95, 20E96, 20ED1, 20ED2, 20ED3, 20EK1 Exp. Date 4/2023; 20F27, 20F28, 20F66, 20F67,20FH6, Exp. Date 05/2023; 20G47, 20G48, 20G49, 20G57, 20GB8, 20GE5, 20GE6, Exp. Date 06/2023; 20M41, 20M42, 20M56, 20M66, 20M67, 20MA4, Exp. Date 07/2023; 20S20, 20S22, 20S44, 20S94, Exp. Date 10/2023; 20SA6, 20SA7, 20SE0, Exp. Date 10/2023, 20TE2, 20TG5, Exp. Date 11/2023.
- Postal code
- 07936-1016
- Report date
- Jun 15, 2022
- Product type
- Drugs
- Recall number
- D-0982-2022
- Classification
- Class III
- Recalling firm
- Novartis Pharmaceuticals Corporation
- Product quantity
- 1,187,092 vials
- Termination date
- Feb 28, 2024
- Reason for recall
- Failed Impurities/Degradation Specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-0911-05) Rx Only, Manufactured by: The Ritedose Corporation, Columbia, SC 29203, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 10, 2022
- Initial firm notification
- Letter
- Center classification date
- Jun 6, 2022