SOMERSET THERAPEUTICS LLC recalls Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Holly…

Recall date

June 4, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1375-2020

FDA classification

Class III

Brand / firm

SOMERSET THERAPEUTICS LLC

Sold / distributed

Nationwide

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-233-01