Recalls / Class III
Class IIID-0982-2022
Product
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.
- Brand name
- Xiidra
- Generic name
- Lifitegrast
- Active ingredient
- Lifitegrast
- Route
- Ophthalmic
- NDC
- 0078-0911
- FDA application
- NDA208073
- Affected lot / code info
- 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.
Why it was recalled
Failed Impurities/Degradation Specifications.
Recalling firm
- Firm
- Novartis Pharmaceuticals Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Health Plz, East Hanover, New Jersey 07936-1016
Distribution
- Quantity
- 1,187,092 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-05-10
- FDA classified
- 2022-06-06
- Posted by FDA
- 2022-06-15
- Terminated
- 2024-02-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0982-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.