FDA recall D-0138-2017

Product

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-10-20

Report date

2016-11-23

Termination date

2017-09-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wilmington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0138-2017