BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION

Generic: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE

Leading PharmaManufacturer
OPHTHALMICRoute
BRIMONIDINE TARTRATEActive Substance
2025-02-25Original Approval

BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION is FDA application ANDA219093, sponsored by CAPLIN. 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 III2020-06-04
Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollyw

Failed Impurities/Degradation Specification: There is a slow leaching process from the product labe

Class III2020-06-04
Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollyw

Failed Impurities/Degradation Specification: There is a slow leaching process from the product labe

Class III2020-06-04
Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywo

Failed Impurities/Degradation Specification: There is a slow leaching process from the product labe

Class II2025-05-28
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex In

Lack of Assurance of Sterility

Top Reported Reactions

1
EYE PAIN
292 reports
2
EYE IRRITATION
227 reports
3
FATIGUE
208 reports
4
DRUG INEFFECTIVE
206 reports
5
OCULAR HYPERAEMIA
186 reports
6
HEADACHE
185 reports
7
VISION BLURRED
174 reports
8
OFF LABEL USE
162 reports
9
PRODUCT DOSE OMISSION ISSUE
140 reports
10
DIZZINESS
137 reports