FDA (Drugs) recall action 75490
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
CutisPharma is recalling 5,904 kits of FIRST Omeprazole 2mg/mL because the package insert incorrectly lists the strength as 3mg/mL.
CutisPharma is recalling 8,748 Omeprazole compounding kits because the package insert incorrectly lists the strength as 3mg/mL instead of 2mg/mL.