# FDA recall D-0390-2019

> **LUPIN SOMERSET** · Class II · drug recall initiated 2019-01-15.

## Product

Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-069-60.

## Reason for recall

Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0390-2019
- **Recalling firm:** LUPIN SOMERSET
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-01-15
- **Report date:** 2019-01-30
- **Termination date:** 2023-02-17

- **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-0390-2019

## Citation

> AI Analytics. FDA recall D-0390-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0390-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*