Somerset Therapeutics, LLC has recalled 455,077 bottles of Brimonidine Tartrate Ophthalmic Solution 0.2%, a prescription eye drop used to treat glaucoma or ocular hypertension. The recall was initiated because substances from the bottle's label are slowly leaching through the plastic container and into the solution. This defect was discovered during a shelf-life impurity and degradation test, affecting 5 mL, 10 mL, and 15 mL bottle sizes distributed nationwide.
The leaching process introduces unauthorized impurities and degradation products into the eye drops, which may compromise the medication's safety and effectiveness over its shelf life. Using contaminated eye drops could lead to reduced treatment efficacy or unexpected adverse reactions in the eye.
Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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