fda
2 records
FDA Drug Recall: FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only,
2016-11-23
Class III — 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
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FDA Drug Recall: FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx onl
2016-11-23
Class III — 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
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