Reported Jun 15, 2022 · Terminated
Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each…
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% 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 forShire US Inc., 300 Shire Way, Lexington, MA 02421
- Lot codes and dates
Lot #: a) and b) 19F39Exp. Date 06/202219P27Exp. Date 10/202220CD1Exp. Date 03/2023
- Amount recalled
- 279,179 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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