FDA Drug recall D-0138-2017
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-0…
- FDA Drug
- Class III
- terminated
- Published 2016-11-23
On 2016-11-23 the FDA classified a Class III recall of FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-0… by Cutispharma, citing 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 2m….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0138-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-10-20 |
| Published | 2016-11-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Cutispharma |
| Distribution | US |
Product
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05
Reason
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
Identifiers
| code_info | Lot #: E1414, Exp. 08/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0138-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.