FDA Drug recall D-1375-2020
Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024
- FDA Drug
- Class III
- terminated
- Published 2020-07-15
On 2020-07-15 the FDA classified a Class III recall of Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024 by Somerset Therapeutics, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1375-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-06-04 |
| Published | 2020-07-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Somerset Therapeutics |
| Distribution | US |
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
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.
Identifiers
| ndc | 70069-231-01 |
|---|---|
| ndc | 70069-232-01 |
| ndc | 70069-233-01 |
| code_info | Lot #s BRM13W9001, BRM13W9002, BRM13W9003, EXP Dec. 2020: BRM13W9004, EXP Apr. 2021. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Somerset Therapeutics
- Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset…
FDA Drug · Class II · 2026-03-25 · Somerset Therapeutics - Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset The…
FDA Drug · Class III · 2025-12-24 · Somerset Therapeutics - Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Th…
FDA Drug · Class III · 2025-12-24 · Somerset Therapeutics - Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerse…
FDA Drug · Class III · 2025-12-24 · Somerset Therapeutics - Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC…
FDA Drug · Class III · 2025-01-08 · Somerset Therapeutics
All Somerset Therapeutics recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1375-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.