FDA recall D-0363-2023

Product

Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16.

Reason for recall

Subpotent Drug

Distribution

Nationwide in the US.

Key facts

Status

Terminated

Initiation date

2023-02-24

Report date

2023-03-08

Termination date

2023-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Windsor, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0363-2023