# FDA recall D-0007-2019

> **Dr. Reddy's Laboratories, Inc.** · Class II · drug recall initiated 2018-09-21.

## Product

Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Distributor: Dr. Reddy's Laboratories, Inc. 107 College Road East, Princeton, NJ - 08540 Rx Only Made in India

## Reason for recall

Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-0007-2019
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-09-21
- **Report date:** 2018-10-10
- **Termination date:** 2023-02-17

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0007-2019

## Citation

> AI Analytics. FDA recall D-0007-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0007-2019. Source: US FDA. Licensed CC0.

---

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