# FDA recall D-0598-2018

> **Dr. Reddy's Laboratories, Inc.** · Class III · drug recall initiated 2018-03-08.

## Product

Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Manufactured by: DPT,  Laboratories Ltd. San Antonio, TX 78215, NDC 43598-341-90

## Reason for recall

Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.

## Distribution

Product was distributed Nationwide in the USA.

## Key facts

- **Recall number:** D-0598-2018
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-03-08
- **Report date:** 2018-03-21
- **Termination date:** 2019-04-29

- **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-0598-2018

## Citation

> AI Analytics. FDA recall D-0598-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0598-2018. Source: US FDA. Licensed CC0.

---

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