FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05

Recall Number: D-0138-2017

Firm: CutisPharma, Inc.

Classification: Class III

Status: Terminated

Report Date: 20161123

Initiation Date: 20161020

Termination Date: 20170912

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

FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05