FDA Recall D-0326-2023
Consolidated Chemical, Inc · Saint Louis, MO
Class II Ongoing 1220 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Recall record
- Recall number
D-0326-2023- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2023-01-10
- Classified by FDA Center
- 2023-02-15
- FDA published
- 2023-02-22
- Recalling firm
- Consolidated Chemical, Inc
- Firm location
- Saint Louis, MO
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.