Class IITerminated

Timolol Maleate Ophthalmic Solution recall

FDA recall D-0488-2024 · initiated Apr 25, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.

Details

Product: Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ
Recalling company: Fdc Ltd
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: New Jersey Only
Initiated: Apr 25, 2024
FDA report date: May 15, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0488-2024 ↗

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