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Class III · Lower riskRecall completed

FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: E1396, Exp. 08/2018
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forCutisPharma Wilmington, MA
NDC65628-070-03
Show the full FDA record
Full product labelFIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03
Recalling firmCutisPharma, Inc.
DistributionNationwide
Quantity5904 kits
Recall initiated2016-10-20
Report date2016-11-23
Recall completed2017-09-12
Recall numberD-0139-2017
ClassificationClass III
FDA statusTerminated
Origin on fileWilmington MA United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.