Class II · Moderate risk
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Betimol (timolol ophthalmic solution)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Affected NDC
82584-0002-15
Compare with the code on your package — it is the most precise check available.
Drug: Timolol Category: Eye Drops & Ophthalmic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Betimol timolol NDC 82584-0002 |
5.12 mg/mL | Solution/ Drops Ophthalmic |
Thea Pharma Inc. | Rx |
- Recalling firm
- Thea Pharma, Inc.
- NDC code
- 82584-002-15
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0374-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Timolol recalls
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Class II · Moderate risk
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*
Lack of Assurance of Sterility
Class II · Moderate risk
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution USP
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Class II · Moderate risk
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Lack of Assurance of Sterility
Other recalls by Thea Pharma, Inc.
All 2024 recalls
Class II · Moderate risk
Similasan
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Class II · Moderate risk
iVIZIA
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
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