FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit — Class III drug recall D-0139-2017
Terminated recall by CutisPharma, Inc., reported 2016-11-23, distributed nationwide. Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package in
| Recall number | D-0139-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CutisPharma, Inc., Wilmington, MA, United States |
| Recall initiated | 2016-10-20 |
| Classified | 2016-11-16 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2017-09-12 |
| Distributed | Nationwide (US) |
| Quantity | 5,904 kits |
| Reason classes | labeling, potency |
| NDC | 65628-0070-03 |
| Lot numbers | E1396 |
| Expiration dates | 2018-08 |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0139-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.