Drug product
Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139.
D-0326-2023
Product summary
- Event
- Event 91521
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3186 bottles
- Official record key
drug-enforcement:D-0326-2023
Official wording
Reason: CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Code information: Lot, expiry: Lot 3216, exp 04/23 and 3218, exp 10/23
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations: initiated due to violations