FDA-Drug2020-07-15Class III
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
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
48,852 bottles
Manufactured in
300 Franklin Square Dr, Somerset, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1374-2020Don't want to check this manually?
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