CutisPharma recalls
FDA enforcement reports naming CutisPharma, Inc. as the recalling firm.
- Recall reports
- 2
- Class I (serious)
- 0
- Most recent report
- Nov 23, 2016
- Nov 23, 2016FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 ozDrug · CutisPharma, Inc.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 mLClass III
- Nov 23, 2016FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manuf…Drug · CutisPharma, Inc.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 mLClass III