SOMERSET THERAPEUTICS LLC: Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-231-01

Is my product affected?

Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-231-01

• Brand BRIMONIDINE TARTRATE

Check against the official notice below — it lists the full affected range.

What happened

Somerset Therapeutics LLC is recalling Brimonidine Tartrate Ophthalmic Solution 0.2% in 5 mL bottles nationwide due to a failed impurities and degradation specification. The issue involves a slow leaching process from the product label on the bottle that may impact the product over its shelf life. The recall affects 383,437 bottles across multiple lots with expiration dates ranging from November 2020 through May 2021.

The affected lots are: BRM11W9001, BRM11W9002, BRM11W9003 (expiring November 2020); BRM11W9004, BRM11W9005, BRM11W9006 (expiring December 2020); BRM11W9007, BRM11W9008, BRM11W9009 (expiring March 2021); BRM11W9010, BRM11W9011, BRM11W9012, BRM11W9013 (expiring April 2021); and BRM11W9014, BRM11W9015 (expiring May 2021). The source does not specify a remedy or what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.

Details from the source

Reason for recall: Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life. Distribution: Nationwide Quantity: 383,437 bottles Lot/code info: Lots # BRM11W9001, BRM11W9002, BRM11W9003, EXP Nov 2020; BRM11W9004, BRM11W9005, BRM11W9006, EXP Dec 2020; BRM11W9007, BRM11W9008, BRM11W9009, EXP Mar 2021; BRM11W9010, BRM11W9011, BRM11W9012, BRM11W9013, EXP Apr 2021; BRM11W9014, BRM11W9015, EXP May 2021

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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