Class IITerminated

Betimol (timolol ophthalmic solution) 0.5% recall

FDA recall D-0374-2024 · initiated Mar 5, 2024

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

Why it was recalled

Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.

Details

Product: Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Recalling company: Thea Pharma
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: Product was distributed nationwide within the United States
Initiated: Mar 5, 2024
FDA report date: Mar 20, 2024

This recall is linked to a product we cover: Betimol →

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-0374-2024 ↗

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