D-1316-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 17, 2022
- Initiation Date
- June 29, 2022
- Termination Date
- February 13, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 boxes
Product Description
Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ) bottle per box, Alcon, NDC 0065-1433-02.
Reason for Recall
CGMP Deviations: products were stored outside the drug label specifications.
Distribution Pattern
Nationwide in the USA.
Code Information
Part# 0065143302