The Recall Desk
LowFDA (Drugs)·D-1375-2020·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 recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or packaging-related issues.

Plain-English summary

Somerset Therapeutics, LLC is recalling Brimonidine Tartrate Ophthalmic Solution 0.2%, 15 mL bottles. The recall involves 22,788 bottles distributed nationwide. The affected lots are BRM13W9001, BRM13W9002, and BRM13W9003 with an expiration date of December 2020, and lot BRM13W9004 with an expiration date of April 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. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers and healthcare providers should stop using the affected bottles and contact their healthcare provider or pharmacist for further instructions. The product is a prescription-only medication manufactured for Somerset Therapeutics, LLC in Hollywood, FL, and made in India.

The recalled product

Product
BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE)
Brand
BRIMONIDINE TARTRATE
Manufacturer
SOMERSET THERAPEUTICS LLC
Category
Drug — Ophthalmic Solution
Hazard
Affected units
22,788

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 (5)

  • Lot #s BRM13W9001
  • BRM13W9002
  • BRM13W9003
  • EXP Dec. 2020: BRM13W9004
  • 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 →