FDA recall D-0061-2018

SCA Pharmaceuticals, LLC · Class II · drug

Product

HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL (HYDROmorphone Total Dose 1000 mcg) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0331-22

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-0061-2018