Novartis Pharmaceuticals Corporation recalls Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use contain…
- Recall date
- May 10, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0983-2022
- FDA classification
- Class III
- Brand / firm
- Novartis Pharmaceuticals Corporation
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Failed Impurities/Degradation Specifications.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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