D-0985-2022 Class III Terminated
FDA drug recall D-0985-2022 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 54092-606-07) and b) 4 pouches x 5 single-use containers (NDC 54092-606-04), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.
Reason for recall
Failed Impurities/Degradation Specifications.
Distribution pattern
Nationwide within the United States
Code information
Lot #: a) and b) 19F39, Exp. Date 06/2022; 19P27, Exp. Date 10/2022; 20CD1, 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-0985-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026