CutisPharma Recalls
2 recalls on record · November 23, 2016 to November 23, 2016 · Drugs
November 23, 2016DrugsFDA
CutisPharma, Inc. recalls FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmingto
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
November 23, 2016DrugsFDA
CutisPharma, Inc. recalls FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmingt
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