# FDA recall D-1518-2019

> **Lupin Pharmaceuticals Inc.** · Class III · drug recall initiated 2019-07-17.

## Product

Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-545-01

## Reason for recall

Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-1518-2019
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-07-17
- **Report date:** 2019-07-31
- **Termination date:** 2020-09-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Baltimore, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1518-2019

## Citation

> AI Analytics. FDA recall D-1518-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1518-2019. Source: US FDA. Licensed CC0.

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