FDA recall D-0326-2023
Consolidated Chemical, Inc · Class II · drug
Product
Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139.
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-0326-2023