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FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured f...

FDA Recall #D-0138-2017 — Class III — October 20, 2016

Recall #D-0138-2017 Date: October 20, 2016 Classification: Class III Status: Terminated

Product Description

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

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

8,748 kits

Distribution

Nationwide

Code Information

Lot #: E1414, Exp. 08/2018

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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