Class II · Moderate risk Ongoing
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution
Reason Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Timolol Maleate Ophthalmic Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
What was recalled
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 firm
- FDC Limited
- NDC code
- 64980-514-05
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0488-2024
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Timolol recalls
See all
Class II · Moderate risk Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Reason Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution USP
Reason Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Class II · Moderate risk Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Reason Lack of Assurance of Sterility
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