Class II
Ongoing
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
This recall is currently active, issued October 29, 2025. It was issued by Usv Private Limited.
- Company
- Usv Private Limited
- Recall Initiated
- October 9, 2025
- Posted
- October 29, 2025
- Recall Number
- D-0034-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8,952 bottles
- Firm Location
- Dabhel, Daman, India
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: 35000409, Exp. Date 01/2026
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