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
D-0325-2023
Product summary
- Event
- Event 91521
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 oz: 6580 bottles; 8 oz: 1248 bottles
- Official record key
drug-enforcement:D-0325-2023
Official wording
Reason: CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Code information: Lots 3217A and 3217B, exp 06/23
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations: initiated due to violations