FDA-Drug2020-07-15Class III

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

SOMERSET THERAPEUTICS LLC
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.

Sold states
Nationwide
Affected count
22,788 bottles
Manufactured in
300 Franklin Square Dr, Somerset, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1375-2020

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