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.
Reported: June 15, 2022 Initiated: May 10, 2022 #D-0983-2022
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications.
Details
- Recalling Firm
- Novartis Pharmaceuticals Corporation
- Units Affected
- 1,253,862 vials
- Distribution
- Nationwide within the United States
- Location
- East Hanover, NJ
Frequently Asked Questions
What product 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.. Recalled by Novartis Pharmaceuticals Corporation. Units affected: 1,253,862 vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 15, 2022. Severity: Low. Recall number: D-0983-2022.
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