Novartis Pharmaceuticals Corporation: Drug Recall
Recall #D-0984-2022 · 05/10/2022
Class III: Low Risk
Recall Details
- Recall Number
- D-0984-2022
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Novartis Pharmaceuticals Corporation
- Status
- Terminated
- Date Initiated
- 05/10/2022
- Location
- East Hanover, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 279,179 vials
Reason for Recall
Failed Impurities/Degradation Specifications.
Product Description
Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-95) and b) 4 pouches x 5 single-use containers (NDC 0078-0911-94), Rx Only, Manufactured by: The Ritedose Corporation Columbia, SC 29203; Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936.
Distribution Pattern
Nationwide within the United States
Other Recalls by Novartis Pharmaceuticals Corporation
- Class I: Dangerous 11/22/2023
- Class II: Risk 09/16/2022
- Class III: Low Risk 05/10/2022
- Class III: Low Risk 05/10/2022
- Class III: Low Risk 05/10/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.