⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

USV Private Limited: Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge,

DrugsSource: FDA (drug) · Date: 2025-10-29

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
USV Private Limited
Product
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 / hazard
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide within the United States
Recall initiated
2025-10-09
Code info
Lot #: 35000409, Exp. Date 01/2026
Product quantity
8,952 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Dabhel, Daman
Country
India
Event id
97766
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