# FDA recall D-0636-2021

> **Teligent Pharma, Inc.** · Class II · drug recall initiated 2021-05-14.

## Product

Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, Rx only, Manufactured by: Teligent Pharma, Inc, Buena, NJ  08310.

## Reason for recall

Presence of Foreign Substance: Foreign particles observed during routine stability testing.

## Distribution

Nationwide in the United States

## Key facts

- **Recall number:** D-0636-2021
- **Recalling firm:** Teligent Pharma, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-05-14
- **Report date:** 2021-06-30
- **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-0636-2021

## Citation

> AI Analytics. FDA recall D-0636-2021. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/D-0636-2021. Source: US FDA. Licensed CC0.

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