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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