Xiidra recall: Impurity Out of Spec
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.
Why was Xiidra recalled?
Failed Impurities/Degradation Specifications.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: a) and b) 19F39, Exp. Date 06/2022; 19P27, Exp. Date 10/2022; 20CD1, Exp. Date 03/2023
- 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.
- Recalling firm
- Novartis Pharmaceuticals Corporation
- Quantity
- 279,179 vials
- Distribution
- Nationwide within the United States
- Recall date
- June 15, 2022
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)