FDAOctober 20, 2016drug
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03
Official recall recorded by the U.S. Food & Drug Administration.
The 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
What to do
FDA enforcement status: Terminated
Brands named
cutispharma
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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