FDA-Drug2025-10-29Class II
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
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Sold states
Nationwide within the United States
Affected count
8,952 bottles
Manufactured in
H-13, 16, 16a, 17, 18, 19, 20, 21 & E-22, Oidc, Mahatma Gandhi Udyog Nagar, Dabhel, Daman, India
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0034-2026Want us to check the next one for you?
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