FDA recall D-0325-2023

Consolidated Chemical, Inc · Class II · drug

Product

Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139. NDC 4 oz bottle: 46706-222-01; NDC 8 oz: 46706-222-02

Reason for recall

CGMP Deviations: initiated due to violations of CGMP manufacturing practices

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2023-01-10
Report date
2023-02-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Louis, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0325-2023