# FDA recall D-1440-2014

> **Fougera Pharmaceuticals  Inc.** · Class III · drug recall initiated 2014-07-03.

## Product

Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.

## Reason for recall

Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1440-2014
- **Recalling firm:** Fougera Pharmaceuticals  Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-07-03
- **Report date:** 2014-07-23
- **Termination date:** 2015-12-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Melville, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1440-2014

## Citation

> AI Analytics. FDA recall D-1440-2014. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1440-2014. Source: US FDA. Licensed CC0.

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