Home / Recalls / CutisPharma, Inc. / D-0139-2017

D-0139-2017 Class III Terminated

Recalled by CutisPharma, Inc. — Wilmington, MA

Recall Details

Product Type: Drugs
Report Date: November 23, 2016
Initiation Date: October 20, 2016
Termination Date: September 12, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5904 kits

Product Description

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 Pattern

Nationwide

Code Information

Lot #: E1396, Exp. 08/2018