FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03
Reported: November 23, 2016 Initiated: October 20, 2016 #D-0139-2017
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
Details
- Recalling Firm
- CutisPharma, Inc.
- Units Affected
- 5904 kits
- Distribution
- Nationwide
- Location
- Wilmington, MA
Frequently Asked Questions
What product was recalled? ▼
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03. Recalled by CutisPharma, Inc.. Units affected: 5904 kits.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 23, 2016. Severity: Low. Recall number: D-0139-2017.
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