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
Reported: October 29, 2025 Initiated: October 9, 2025 #D-0034-2026
Product Description
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 for Recall
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Details
- Recalling Firm
- USV Private Limited
- Units Affected
- 8,952 bottles
- Distribution
- Nationwide within the United States
- Location
- Dabhel, Daman
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by USV Private Limited. Units affected: 8,952 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 29, 2025. Severity: Moderate. Recall number: D-0034-2026.
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