Ophthalmic Solution Xiidra Recalled for Failed Impurities and Degradation
Novartis is recalling Xiidra ophthalmic solution professional samples nationwide due to failed impurities and degradation specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is classified as an FDA Class III recall with no reported illnesses or injuries, placing it in the Moderate category. The failed quality specifications warrant a precautionary recall, but the absence of reported adverse effects supports the lower severity classification.
Plain-English summary
Novartis Pharmaceuticals Corporation is recalling Xiidra (lifitegrast) ophthalmic solution 5% professional samples nationwide due to failed impurities and degradation specifications. The recall involves 279,179 vials with lot number 20DJ3 and expiration date March 2023.
The affected samples were distributed across the United States to healthcare facilities and practices. Xiidra is a prescription ophthalmic medication used to treat dry eye disease. As a professional sample product, these were intended for healthcare provider distribution and use.
The recalled product
- Product
- XIIDRA (LIFITEGRAST)
- Brand
- XIIDRA
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Category
- Drug — Ophthalmic Solution
- Hazard
- impurities
- degradation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: a) and b) 20DJ3
- Exp. Date 03/2023.
Distribution
Distributed nationwide across the United States.
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- ModerateOphthalmic Drug Xiidra Recalled for Failed Impurity Specifications
FDA (Drugs) · 2022-06-15
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