Recalls / Class III
Class IIID-0985-2022
Product
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.
- Affected lot / code info
- Lot #: a) and b) 19F39, Exp. Date 06/2022; 19P27, Exp. Date 10/2022; 20CD1, Exp. Date 03/2023
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
- 279,179 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-0985-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.