D-1320-2022 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
- 40 boxes
Product Description
GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.
Reason for Recall
CGMP Deviations: products were stored outside the drug label specifications.
Distribution Pattern
Nationwide in the USA.
Code Information
Part# 30065051801