Brimonidine Tartrate Opthalmic Solution 0 — Class III drug recall D-1375-2020
Terminated recall by SOMERSET THERAPEUTICS LLC, reported 2020-07-15, distributed nationwide. Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bo
| Recall number | D-1375-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SOMERSET THERAPEUTICS LLC, Somerset, NJ, United States |
| Recall initiated | 2020-06-04 |
| Classified | 2020-07-07 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2023-06-30 |
| Distributed | Nationwide (US) |
| Quantity | 22,788 bottles |
| Reason classes | labeling, specification failure |
| NDC | 70069-0231, 70069-0231-01, 70069-0232, 70069-0232-01, 70069-0233, 70069-0233-01 |
| Lot numbers | BRM13W9001, BRM13W9002, BRM13W9003, BRM13W9004 |
| Expiration dates | 2020-12-20, 2021-04-20 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1375-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.