The Recall Desk
LowFDA (Drugs)·D-1373-2020·Announced 2020-07-15

Somerset Therapeutics Recalls Brimonidine Tartrate Ophthalmic Solution Due to Label Leaching

Somerset Therapeutics is recalling 383,437 bottles of Brimonidine Tartrate Ophthalmic Solution 0.2% because a slow leaching process from the product label 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 agency classified this as an FDA 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 low severity.

Plain-English summary

Somerset Therapeutics, LLC is recalling 383,437 bottles of Brimonidine Tartrate Ophthalmic Solution 0.2%, 5 mL, prescription only. The product is manufactured for Somerset Therapeutics, LLC in Hollywood, FL, and made in India. The recall covers specific lots with expiration dates ranging from November 2020 to May 2021, including lot numbers BRM11W9001 through BRM11W9015.

The recall was initiated due to a failed impurities/degradation specification. The source text states that there is a slow leaching process from the product label on the bottle which may impact the product over the shelf life. The agency 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.

The product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement, or disposed of according to local regulations for prescription medications.

The recalled product

Product
BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE)
Brand
BRIMONIDINE TARTRATE
Manufacturer
SOMERSET THERAPEUTICS LLC
Category
Drug — Ophthalmic Solution
Hazard
Affected units
383,437

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 (20)

  • 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

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 →