Reported Jun 15, 2022 · Terminated
Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use…
Novartis Pharmaceuticals Corporation
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Novartis Pharmaceuticals Corporation · 1 Health Plz · East Hanover, NJ · 07936-1016
Is this the product you have?
- Xiidra (lifitegrast ophthalmic solution) 5%
- packaged in a) 60 Single-Use Containers12 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 forShire US Inc., 300 Shire Way, Lexington, MA 02421
- Lot codes and dates
Lot #: a) and b)19E3119E3219E8519E8619EC019EG8 & 19EG9Exp. Date 05/202219F1319FB0 & 19FC5Exp. Date 6/202219G3319G3419GJ8Exp. Date 07/202219M2519M26 & 19M68Exp. Date 08/202219NC019NC119NF219NF3Exp. Date 09/202219P2619P5919P6019P8519P86 19P87Exp. Date 10/202219S5519S0319S0419S0519S07Exp. Date 11/202219T0619T6019T61Exp. Date 12/202220A3820A3920A6420A6520AA120AA220AC820AC920AE7Exp. Date 01/202320B2420B2520B5520B5620B57 & 20B58Exp. Date 02/2023
- Amount recalled
- 1,253,862 vials
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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