The Recall Desk
LowFDA (Drugs)·D-1374-2020·Announced 2020-07-15

Somerset Therapeutics Recalls Brimonidine Tartrate Ophthalmic Solution

Somerset Therapeutics is recalling Brimonidine Tartrate Ophthalmic Solution 0.2% due to a slow leaching process from the product label that may impact the product over its shelf life.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard involves a slow leaching process from the label that may impact product stability over shelf life, fitting the criteria for cosmetic or packaging-only problems.

Plain-English summary

Somerset Therapeutics, LLC is recalling Brimonidine Tartrate Ophthalmic Solution 0.2%, 10 mL bottles. The recall involves 48,852 bottles distributed nationwide. The affected lots are # BRM12W9001 (EXP 2020), BRM12W9002 and BRM12W9003 (EXP Dec. 2020), and BRM12W9004 (EXP Apr. 2021).

The recall was initiated because of a failed impurities/degradation specification. Specifically, there is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.

Consumers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE)
Brand
BRIMONIDINE TARTRATE
Manufacturer
SOMERSET THERAPEUTICS LLC
Category
Drug — Ophthalmic Solution
Hazard
Affected units
48,852

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • Lots # BRM12W9001
  • EXP 2020
  • BRM12W9002
  • BRM12W9003
  • EXP Dec. 2020
  • BRM12W9004
  • EXP Apr. 2021

UPCs (3)

  • 0370069231012
  • 0370069232019
  • 0370069233016

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by SOMERSET THERAPEUTICS LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same brand · BRIMONIDINE TARTRATE

Same manufacturer · SOMERSET THERAPEUTICS LLC

See all →