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Class III: unlikely to cause harmTerminated

CutisPharma FIRST Omeprazole 2mg/mL in FIRST PPI Recall

FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manuf…

CutisPharma, Inc. · Wilmington, MA

Risk level
Class III
Reported by FDA
Nov 23, 2016
Recall ID
D-0139-2017
Check your lot numberHow we source this data

Summary

CutisPharma recalled FIRST Omeprazole 2mg/mL in FIRST PPI starting Oct 20, 2016. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0139-2017 on Nov 23, 2016. 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. Status: Terminated.

Why it was recalled

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

Product description

FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03

Lot numbers, UPCs & expiration codes

Lot #: E1396, Exp. 08/2018

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0139-2017
Classification
Class III
Status
Terminated
Recall initiated
Oct 20, 2016
FDA report date
Nov 23, 2016
Quantity
5904 kits
Recall type
Voluntary: Firm initiated
Recalling firm
CutisPharma, Inc.

Original FDA data

Every field from FDA enforcement report D-0139-2017, exactly as published.

Show all FDA fields
City
Wilmington
State
MA
Status
Terminated
Country
United States
Event ID
75490
Address
841 Woburn St
Code information
Lot #: E1396, Exp. 08/2018
Postal code
01887-3414
Report date
Nov 23, 2016
Product type
Drugs
Recall number
D-0139-2017
Classification
Class III
Recalling firm
CutisPharma, Inc.
Product quantity
5904 kits
Termination date
Sep 12, 2017
Reason for recall
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
Voluntary / mandated
Voluntary: Firm initiated
Product description
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03
Distribution pattern
Nationwide
Recall initiation date
Oct 20, 2016
Initial firm notification
Letter
Center classification date
Nov 16, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0139-2017, published Nov 23, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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