FDA recall D-1533-2022

Carolina Infusion · Class II · drug

Product

QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide in the USA.

Key facts

Status
Completed
Initiation date
2022-08-26
Report date
2022-09-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ridgeland, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1533-2022