USV Private recalled 8,952 bottles of Olopatadine Hydrochloride Ophthalmic Solution USP 0.1%. The product was distributed nationwide in the United States. The defect is failure of impurities/degradation specifications due to an unspecified impurity exceeding the limit. Stop using immediately and contact USV Private Limited or a healthcare provider for guidance.
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Consumers and healthcare providers should stop using this product immediately. Contact USV Private Limited or your healthcare provider for guidance. Notification method: Letter
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Olopatadine hydrochloride ophthalmic solution is used to treat allergic conjunctivitis by reducing itching in the eyes.
The product failed impurity/degradation specifications due to an unspecified impurity exceeding the limit. The exact health impact is not detailed in the recall.
This recall is not described as part of a broader industry pattern.
Consumers may face unknown health risks from the impurity. The recall affects nearly 9,000 bottles, requiring immediate discontinuation of use and guidance from a healthcare provider.
Label on bottle and external packaging showing NDC, Lot, Exp date; FDA recall page for D-0034-2026.
Refunds or replacements are typically processed within 4-8 weeks after confirmation of eligibility.
Keep the recall letter, photos of the bottle labeling, and all communications with the company. Preserve the bottle and packaging for reference.
Product: Olopatadine Hydrochloride Ophthalmic Solution USP 0.1% 5 mL (0.17 FL OZ) bottles NDC: 70512-0520-05 Lot: 35000409 Exp: 01/2026 Quantity: 8,952 bottles Distributor/Manufacturer: SOLA PHARMACEUTICS LLC, Baton Rouge, LA 70810 Sold nationwide in the United States Price: Not provided
No injuries or incidents have been reported.
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