Class III
Terminated
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05
- Company
- Cutispharma, Inc.
- Recall Initiated
- October 20, 2016
- Posted
- November 23, 2016
- Recall Number
- D-0138-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8,748 kits
- Firm Location
- Wilmington, MA, United States
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
Distribution
Nationwide
Lot / Code Info
Lot #: E1414, Exp. 08/2018
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