FDARecalled Oct 29, 2025 · #D-0034-2026
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
Hazard
Class II — temporary health risk
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Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit. Classification: Class II Distribution: Nationwide within the United States
Product details
- 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
- Type
- Drugs
- Manufacturer
- USV Private Limited
- Model numbers
- 35000409
- UPCs
- —