# FDA recall D-0510-2017

> **LEO PHARMA INC** · Class II · drug recall initiated 2017-01-19.

## Product

Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-877-78), Rx Only,  Manufactured by: LEO Pharma Inc., Dublin, Ireland, Manufactured for: Prasco Laboratories, Mason, OH, 45040

## Reason for recall

Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-0510-2017
- **Recalling firm:** LEO PHARMA INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-01-19
- **Report date:** 2017-03-15
- **Termination date:** 2018-01-24

- **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-0510-2017

## Citation

> AI Analytics. FDA recall D-0510-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0510-2017. Source: US FDA. Licensed CC0.

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