Drug product

Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-232-01

D-1374-2020

June 04, 2020

Class III

Product summary

Firm: SOMERSET THERAPEUTICS LLC
Event: Event 85826
Status: Terminated
Classification: Class III
Quantity: 48,852 bottles
Official record key: drug-enforcement:D-1374-2020

Official wording

Reason: 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.

Code information: Lots # BRM12W9001, EXP 2020; BRM12W9002, BRM12W9003, EXP Dec. 2020; BRM12W9004, EXP Apr. 2021

Distribution pattern: Nationwide

Derived failure modes

Potency or specification failure
reason.potency_specification_failure · v1.0.0

Failed Impurities/Degradation Specification