# FDA recall D-0653-2017

> **Novel Laboratories, Inc.** · Class III · drug recall initiated 2017-02-22.

## Product

Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use,  60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873,   Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC  43386-069-60

## Reason for recall

Chemical Contamination

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0653-2017
- **Recalling firm:** Novel Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-02-22
- **Report date:** 2017-04-19
- **Termination date:** 2019-08-19

- **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-0653-2017

## Citation

> AI Analytics. FDA recall D-0653-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0653-2017. Source: US FDA. Licensed CC0.

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