# FDA recall D-0092-2019

> **LUPIN SOMERSET** · Class II · drug recall initiated 2018-10-05.

## Product

Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC  43386-069-60

## Reason for recall

Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0092-2019
- **Recalling firm:** LUPIN SOMERSET
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-10-05
- **Report date:** 2018-10-31
- **Termination date:** 2022-11-08

- **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-0092-2019

## Citation

> AI Analytics. FDA recall D-0092-2019. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/D-0092-2019. Source: US FDA. Licensed CC0.

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