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Recall Observatory FDA recall evidence

Drug 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

D-0034-2026

October 09, 2025

Class II

Product summary

Firm
USV Private Limited
Event
Event 97766
Status
Ongoing
Classification
Class II
Quantity
8,952 bottles
Official record key
drug-enforcement:D-0034-2026

Official wording

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

Code information: Lot #: 35000409, Exp. Date 01/2026

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications