Xiidra recall: Impurity Out of Spec
Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 54092-606-01) and b) 5-Single-Use Containers (NDC 54092-606-06), 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)19E31, 19E32, 19E85, 19E86, 19EC0, 19EG8 & 19EG9, Exp. Date 05/2022; 19F13, 19FB0 & 19FC5, Exp. Date 6/2022;19G33, 19G34,19GJ8, Exp. Date 07/2022;19M25, 19M26 & 19M68, Exp. Date 08/2022;19NC0, 19NC1, 19NF2,19NF3, Exp. Date 09/2022;19P26, 19P59, 19P60,19P85,19P86 19P87, Exp. Date 10/2022;19S55, 19S03, 19S04, 19S05,19S07, Exp. Date 11/2022; 19T06, 19T60, 19T61, Exp. Date 12/2022; 20A38, 20A39, 20A64, 20A65, 20AA1, 20AA2, 20AC8, 20AC9, 20AE7, Exp. Date 01/2023; 20B24, 20B25, 20B55, 20B56, 20B57 & 20B58, Exp. Date 02/2023
- Product
- Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 54092-606-01) and b) 5-Single-Use Containers (NDC 54092-606-06), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.
- Recalling firm
- Novartis Pharmaceuticals Corporation
- Quantity
- 1,253,862 vials
- Distribution
- Nationwide within the United States
- Recall date
- June 15, 2022
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)