FDA recall D-0945-2023

Product

FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40

Reason for recall

cGMP deviations: due to shipment of rejected units.

Distribution

KY and NJ

Key facts

Status

Terminated

Initiation date

2023-07-20

Report date

2023-08-02

Termination date

2023-09-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Windsor, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0945-2023