TIMOLOL MALEATE

Generic: TIMOLOL MALEATE

Somerset TherapeuticsManufacturer

OPHTHALMICRoute

TIMOLOL MALEATEActive Substance

2024-09-16Original Approval

TIMOLOL MALEATE is FDA application ANDA210640, sponsored by SOMERSET THERAPS LLC. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2026-03-05

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured f

Lack of Assurance of Sterility

Class II2025-09-05

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufacture

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to poten

Class II2024-04-25

Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC

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

Class III2019-11-15

Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed

Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had th

Class II2024-08-12

Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64

Defective Container: patients are unable to get the solution out of the bottle as the spike of the c

Class II2025-04-18

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aura

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged

Class II2024-10-29

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Auran

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged

Class III2019-11-15

Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pha

Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had th

Class II2025-07-05

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Auran

Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.

Class II2026-07-22

Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro La

Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.

TIMOLOL MALEATE

Recalls

Top Reported Reactions