D-0984-2022 Class III Terminated
FDA drug recall D-0984-2022 was initiated by Novartis Pharmaceuticals Corporation on May 10, 2022 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications. The recall status is terminated (terminated Feb 28, 2024). Affected quantity: 279,179 vials.
Recall details
- Product Type
- Drugs
- Report Date
- Jun 15, 2022
- Initiation Date
- May 10, 2022
- Termination Date
- Feb 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 279,179 vials
Product description
Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-95) and b) 4 pouches x 5 single-use containers (NDC 0078-0911-94), Rx Only, Manufactured by: The Ritedose Corporation Columbia, SC 29203; Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936.
Reason for recall
Failed Impurities/Degradation Specifications.
Distribution pattern
Nationwide within the United States
Code information
Lot #: a) and b) 20DJ3, Exp. Date 03/2023.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0984-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026