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

Recall Number: D-0034-2026

Firm: USV Private Limited

Classification: Class II

Status: Ongoing

Report Date: 20251029

Initiation Date: 20251009

Termination Date:

Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.

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