Status
Ongoing
Drug Enforcement D-0326-2023
CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Classification
Class II
Report Date
February 22, 2023
Termination Date
—
Product Information
- Product description
- Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139.
- Product quantity
- 3186 bottles
- Reason for recall
- CGMP Deviations: initiated due to violations of CGMP manufacturing practices
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Consolidated Chemical, Inc
- Address
-
3224 S Kingshighway Blvd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0326-2023
- Event ID
- 91521
- Recall initiation date
- January 10, 2023
- Center classification date
- February 15, 2023
- Code info
- Lot, expiry: Lot 3216, exp 04/23 and 3218, exp 10/23
- More code info
- —