# FDA recall D-0139-2017

> **CutisPharma, Inc.** · Class III · drug recall initiated 2016-10-20.

## Product

FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only,  Manufactured for CutisPharma Wilmington, MA,  NDC# 65628-070-03

## Reason for recall

Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0139-2017
- **Recalling firm:** CutisPharma, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-10-20
- **Report date:** 2016-11-23
- **Termination date:** 2017-09-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wilmington, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0139-2017

## Citation

> AI Analytics. FDA recall D-0139-2017. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0139-2017. Source: US FDA. Licensed CC0.

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