CutisPharma, Inc. recalls FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmingto…

Recall date

October 20, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0139-2017

FDA classification

Class III

Brand / firm

CutisPharma, Inc.

Sold / distributed

Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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