D-0034-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- October 29, 2025
- Initiation Date
- October 9, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,952 bottles
Product Description
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810, NDC 70512-0520-05
Reason for Recall
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 35000409, Exp. Date 01/2026