SOMERSET THERAPEUTICS LLC recalls Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollyw
Recalled July 15, 2020 · FDA recall D-1374-2020 · SOMERSET THERAPEUTICS
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. · FDA Class III
Units
48,852 bottles
Sold at
Nationwide
Description
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.
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
Manufacturer(s)
SOMERSET THERAPEUTICS LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →