Multi event Drug Recall Enforcement Report Class III voluntary initiated by SOMERSET THERAPEUTICS LLC, originally initiated on 06-04-2020 for the 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 The product was recalled due to 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.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-1375-2020 | 06-04-2020 | 07-15-2020 | Class III | 22,788 bottles | 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 | 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. | Terminated |
| D-1373-2020 | 06-04-2020 | 07-15-2020 | Class III | 383,437 bottles | 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 | 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. | Terminated |
| D-1374-2020 | 06-04-2020 | 07-15-2020 | Class III | 48,852 bottles | Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-232-01 | 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. | Terminated |
Recalled Products
