FDA recall D-0063-2018

SCA Pharmaceuticals, LLC · Class II · drug

Product

fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per 100 mL) in 0.9% Sodium Chloride single dose CADD Cassette Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0264-64

Reason for recall

Lack Of Assurance Of Sterility.

Distribution

Nationwide in the United States

Key facts

Status: Terminated
Initiation date: 2017-10-19
Report date: 2017-11-08
Termination date: 2019-05-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0063-2018