RecallDepth
Class III Terminated

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

Company
Somerset Therapeutics Llc
Recall Initiated
June 4, 2020
Posted
July 15, 2020
Recall Number
D-1375-2020
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
22,788 bottles
Firm Location
Somerset, NJ, United States

Reason for Recall

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.

Distribution

Nationwide

Lot / Code Info

Lot #s BRM13W9001, BRM13W9002, BRM13W9003, EXP Dec. 2020: BRM13W9004, EXP Apr. 2021.

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