Multi-event October 2016 FDA Recall Drug by Cutispharma, Inc.

This Multi-event Class III drug recall was voluntarily initiated by Cutispharma, Inc. on October 20, 2016 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0138-2017 TERMINATED D-0139-2017 TERMINATED

Recall Number: D-0138-2017

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
Initiated
10-20-2016
Reported
11-23-2016
Quantity
8,748 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75490
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
CutisPharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-12-2017
Product Description About Product Description
Full technical description of the product.
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05

Batch or Lot Expiration Information

Lot# : E1414, Exp. 08/2018

Recall Number: D-0139-2017

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
Initiated
10-20-2016
Reported
11-23-2016
Quantity
5904 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75490
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
CutisPharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-12-2017
Product Description About Product Description
Full technical description of the product.
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03

Batch or Lot Expiration Information

Lot# : E1396, Exp. 08/2018