FIRST Omeprazole 2mg/mL in FIRST PPI Suspension recall: Labeling Error
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05
Why was FIRST Omeprazole 2mg/mL in FIRST PPI Suspension 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: E1414, Exp. 08/2018
- Product
- FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05
- Recalling firm
- CutisPharma, Inc.
- Quantity
- 8,748 kits
- Distribution
- Nationwide
- Recall date
- November 23, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)