# FDA recall D-0064-2021

> **Teligent Pharma, Inc.** · Class III · drug recall initiated 2020-09-28.

## Product

Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15,  b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310

## Reason for recall

Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.

## Distribution

United States Nationwide

## Key facts

- **Recall number:** D-0064-2021
- **Recalling firm:** Teligent Pharma, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-09-28
- **Report date:** 2020-11-11
- **Termination date:** 2022-08-22

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0064-2021

## Citation

> AI Analytics. FDA recall D-0064-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0064-2021. Source: US FDA. Licensed CC0.

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