Drug product
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05
D-0138-2017
Product summary
- Event
- Event 75490
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8,748 kits
- Official record key
drug-enforcement:D-0138-2017
Official wording
Reason: 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
Code information: Lot #: E1414, Exp. 08/2018
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Label error