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CutisPharma, Inc.

CutisPharma, Inc. Recalls

All product recalls associated with CutisPharma, Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Oct 2016

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–2 of 2 recalls

FIRST Omeprazole Suspension 2mg/mL (CutisPharma) – Labeling Error (2016)

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

Class IIILow

FDAOct 20, 2016Nationwide• CutisPharma, Inc.

FIRST Omeprazole Suspension 2mg/mL (CutisPharma) – Labeling Error (2016)

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

Class IIILow

FDAOct 20, 2016Nationwide• CutisPharma, Inc.