Drug recall D-1375-2020
Product
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
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.
Lots and codes
Lot #s BRM13W9001, BRM13W9002, BRM13W9003, EXP Dec. 2020: BRM13W9004, EXP Apr. 2021.
Recall details
- Recalling firm
- SOMERSET THERAPEUTICS LLC, Somerset, NJ
- Quantity
- 22,788 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 4, 2020
- Terminated
- June 30, 2023
Related products
- Brimonidine Tartrate – drug information
- NDC 70069-232 Brimonidine Tartrate · Brimonidine Tartrate 2 mg/mL · Somerset Therapeutics, LLC
- NDC 70069-233 Brimonidine Tartrate · Brimonidine Tartrate 2 mg/mL · Somerset Therapeutics, LLC
- NDC 70069-231 Brimonidine Tartrate · Brimonidine Tartrate 2 mg/mL · Somerset Therapeutics, LLC