FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured fo...
FDA Recall #D-0139-2017 — Class III — October 20, 2016
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
Recalling Firm
CutisPharma, Inc. — Wilmington, MA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
5904 kits
Distribution
Nationwide
Code Information
Lot #: E1396, Exp. 08/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated