# FDA recall D-1375-2020

> **SOMERSET THERAPEUTICS LLC** · Class III · drug recall initiated 2020-06-04.

## 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 for recall

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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1375-2020
- **Recalling firm:** SOMERSET THERAPEUTICS LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-06-04
- **Report date:** 2020-07-15
- **Termination date:** 2023-06-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Somerset, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1375-2020

## Citation

> AI Analytics. FDA recall D-1375-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1375-2020. Source: US FDA. Licensed CC0.

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