FDAFDA · Food and drugs·Recall number D-0139-2017
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03
Published November 23, 2016 · Recall initiated: October 20, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CutisPharma, Inc.
- Distributor
- Nationwide
- Lot
- Lot #: E1396, Exp. 08/2018
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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