FDA-Drug2016-11-23Class III
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03
CutisPharma, Inc.
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
Sold states
Nationwide
Affected count
5904 kits
Manufactured in
841 Woburn St, N/A, Wilmington, MA, United States
Products
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0139-2017Don't want to check this manually?
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