Cutispharma recalls
Cutispharma appears in 2 official U.S. recall notices indexed by RecallRadar, most recently on 2016-11-23.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 2 |
|---|---|
| Published | 2016-11-23 |
| By agency | FDA Drug (2) |
| By classification | Class III (2) |
| By status | terminated (2) |
| Distribution named in notices | US |
Recalls
- FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-07…
FDA Drug · Class III · 2016-11-23 · Cutispharma
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 - 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 · 2016-11-23 · Cutispharma
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