Reported Jun 15, 2022 · Terminated
Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers…
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)
- packaged in a) 60 Single-Use Containers12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-0911-05) Rx Only
- Manufactured byThe Ritedose Corporation, Columbia, SC 29203
- Distributed byNovartis Pharmaceuticals Corporation, East Hanover, NJ 07936
- Lot codes and dates
Lot #:a) and b) 20E2120E2220E5320E5420E9520E9620ED120ED220ED320EK1 Exp. Date 4/202320F2720F2820F6620F6720FH6Exp. Date 05/202320G4720G4820G4920G5720GB820GE520GE6Exp. Date 06/202320M4120M4220M5620M6620M6720MA4Exp. Date 07/202320S2020S2220S4420S94Exp. Date 10/202320SA620SA720SE0Exp. Date 10/202320TE220TG5Exp. Date 11/2023
- Amount recalled
- 1,187,092 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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