D-1373-2020 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 15, 2020
- Initiation Date
- June 4, 2020
- Termination Date
- June 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 383,437 bottles
Product Description
Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-231-01
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 Pattern
Nationwide
Code Information
Lots # BRM11W9001, BRM11W9002, BRM11W9003, EXP Nov 2020; BRM11W9004, BRM11W9005, BRM11W9006, EXP Dec 2020; BRM11W9007, BRM11W9008, BRM11W9009, EXP Mar 2021; BRM11W9010, BRM11W9011, BRM11W9012, BRM11W9013, EXP Apr 2021; BRM11W9014, BRM11W9015, EXP May 2021