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
Product summary
- 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
Failed Impurities/Degradation Specifications