Drug 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
D-1375-2020
Product summary
- Event
- Event 85826
- Status
- Terminated
- Classification
- Class III
- Quantity
- 22,788 bottles
- Official record key
drug-enforcement:D-1375-2020
Official wording
Reason: 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.
Code information: Lot #s BRM13W9001, BRM13W9002, BRM13W9003, EXP Dec. 2020: BRM13W9004, EXP Apr. 2021.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specification