D-0139-2017 Class III Terminated
FDA drug recall D-0139-2017 was initiated by CutisPharma, Inc. on October 20, 2016 and is designated Class III. 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 The recall status is terminated (terminated September 12, 2017). Affected quantity: 5904 kits.
Recall Details
- Product Type
- Drugs
- Report Date
- November 23, 2016
- Initiation Date
- October 20, 2016
- Termination Date
- September 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5904 kits
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
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 Pattern
Nationwide
Code Information
Lot #: E1396, Exp. 08/2018