CutisPharma, Inc. recalls FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmingt

Recalled November 23, 2016 · FDA recall D-0138-2017 · CutisPharma

Hazard

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 · FDA Class III

Units

8,748 kits

Sold at

Nationwide

Description

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

Product

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

Manufacturer(s)

CutisPharma, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →