# FDA recall D-0477-2017

> **LEO PHARMA INC** · Class III · drug recall initiated 2017-01-16.

## Product

Taclonex (calcipotriene and betamethasone dipropionate)  Topical Suspension, 0.005%/0.064%, packaged in (a) 60 g (NDC 50222-501-06), and  (b)120 g (50222-501-66)  tubes,  Rx Only, Manufactured by: LEO Laboratories Ltd., 285 Cashel Road, Dublin 12 Ireland, Distributed by: LEO Pharma Inc. 1 Sylvan Way, Parsippany, NJ 07054.

## Reason for recall

Labeling: Incorrect or missing package insert:  the affected product was packaged with an out-of-date package insert (PI) dated February 2014.

## Distribution

Nationwide within US

## Key facts

- **Recall number:** D-0477-2017
- **Recalling firm:** LEO PHARMA INC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-01-16
- **Report date:** 2017-02-22
- **Termination date:** 2017-12-12

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0477-2017

## Citation

> AI Analytics. FDA recall D-0477-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0477-2017. Source: US FDA. Licensed CC0.

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