Xiidra Ophthalmic Solution Recalled for Failed Impurity and Degradation Specifications
Novartis is recalling Xiidra (lifitegrast ophthalmic solution) 5% professional samples nationwide due to failed impurities and degradation quality specifications. The recall affects 279,179 vials across three lot numbers.
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 an FDA Class III recall with no reported illnesses or injuries. The hazard is failed quality specifications for impurities and degradation, which is a precautionary quality control issue without a confirmed specific health threat.
Plain-English summary
Novartis Pharmaceuticals Corporation is recalling specific lots of Xiidra (lifitegrast ophthalmic solution) 5% professional samples distributed nationwide. The recall was initiated because these units failed impurities and degradation quality specifications during manufacturing.
The affected product is available in two package configurations: 5 single-use containers (0.2 mL each vial) with NDC 54092-606-07, or 4 pouches containing 5 single-use containers each with NDC 54092-606-04. A total of 279,179 vials are affected across three lot numbers: 19F39 (expiration 06/2022), 19P27 (expiration 10/2022), and 20CD1 (expiration 03/2023).
Xiidra is a prescription ophthalmic solution. Patients who have received product from these lots should contact their healthcare provider to discuss whether they need a replacement. Healthcare providers should check their inventories for the recalled lot numbers and isolate any affected units from use.
The recalled product
- Product
- 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 for: Shire US Inc., 300 Shire Way, Lexington, MA 0242
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Category
- Drug — Ophthalmic
- Hazard
- impurity-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 (6)
- Lot #: a) and b) 19F39
- Exp. Date 06/2022
- 19P27
- Exp. Date 10/2022
- 20CD1
- Exp. Date 03/2023
Distribution
Distributed nationwide across the United States.
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