# FDA recall D-0338-2021

> **Teligent Pharma, Inc.** · Class III · drug recall initiated 2021-02-02.

## Product

Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in  15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15

## Reason for recall

Failed Impurities/ Degradation Specifications -  OOS for know impurity Betamethasone 17- propionate.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0338-2021
- **Recalling firm:** Teligent Pharma, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-02-02
- **Report date:** 2021-05-05
- **Termination date:** 2024-08-15

- **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-0338-2021

## Citation

> AI Analytics. FDA recall D-0338-2021. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0338-2021. Source: US FDA. Licensed CC0.

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