NDC 70069-233
Brimonidine Tartrate 2 mg per 1 mL solution/ drops
On the label: Somerset Therapeutics, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Somerset Therapeutics Private Limited | Bengaluru, India | Makes it, tests it, packages it and labels it | Serious problems, FDA actionFeb 21, 2025 · 10 inspections, 4 with FDA action |
Recalls
- Jun 4, 2020 · Class III · Somerset Therapeutics Llc
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: Lots # BRM11W9001, BRM11W9002, BRM11W9003, EXP Nov 2020; BRM11W9004, BRM11W9005, BRM11W9006, EXP Dec 2020; BRM11W9007, BRM11W9008, BRM11W9009, EXP Mar 2021; BRM11W9010, BRM11W9011, BRM11W9012, BRM11W9013, EXP Apr 2021; BRM11W9014, BRM11W9015, EXP May 2021 - Jun 4, 2020 · Class III · Somerset Therapeutics Llc
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: Lots # BRM12W9001, EXP 2020; BRM12W9002, BRM12W9003, EXP Dec. 2020; BRM12W9004, EXP Apr. 2021 - Jun 4, 2020 · Class III · Somerset Therapeutics Llc
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: Lot #s BRM13W9001, BRM13W9002, BRM13W9003, EXP Dec. 2020: BRM13W9004, EXP Apr. 2021.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Brimonidine: every company that makes it
- Form
- solution/ drops, ophthalmic
- Strength
- 2 mg per 1 mL
- Approval
- ANDA ANDA208992
- On the market since
- Mar 11, 2019
- Package NDCs
70069-233-01- Official label
- DailyMed (National Library of Medicine), updated Mar 22, 2025
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