Xiidra ophthalmic solution recalled for failed impurity and degradation specifications
Novartis recalls approximately 1.25 million vials of Xiidra ophthalmic solution nationwide due to failed impurity and degradation specifications. Patients using this product should contact their healthcare provider.
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: FDA Class III recall with no reported illnesses or injuries. The hazard relates to failed impurity and degradation specifications, representing a quality control issue rather than an acute safety threat.
Plain-English summary
Novartis Pharmaceuticals Corporation is recalling Xiidra (lifitegrast ophthalmic solution) 5% due to failed impurities and degradation specifications. The product failed quality control specifications related to impurities and product degradation.
Approximately 1.25 million vials have been distributed nationwide within the United States. The recall includes multiple lot numbers with expiration dates ranging from May 2022 through February 2023.
Patients currently using this medication should contact their healthcare provider or pharmacist to determine if their supply is affected and whether an alternative should be used.
The recalled product
- Product
- 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,
- 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 (20)
- Lot #: a) and b)19E31
- 19E32
- 19E85
- 19E86
- 19EC0
- 19EG8 & 19EG9
- Exp. Date 05/2022
- 19F13
- 19FB0 & 19FC5
- Exp. Date 6/2022
- 19G33
- 19G34
- 19GJ8
- Exp. Date 07/2022
- 19M25
- 19M26 & 19M68
- Exp. Date 08/2022
- 19NC0
- 19NC1
- 19NF2
Distribution
Distributed nationwide across the United States.
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