# FDA recall D-0515-2019

> **Akorn Inc** · Class III · drug recall initiated 2019-01-25.

## Product

Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.

## Reason for recall

Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.

## Distribution

Nationwide, including Puerto Rico.

## Key facts

- **Recall number:** D-0515-2019
- **Recalling firm:** Akorn Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-01-25
- **Report date:** 2019-02-27
- **Termination date:** 2020-11-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0515-2019

## Citation

> AI Analytics. FDA recall D-0515-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0515-2019. Source: US FDA. Licensed CC0.

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