Drug product
Kill 'Dat Sanitizing Products Hand Sanitizer, 1 gallon (128 fl. oz.) 80% Alcohol, OTC, Manufactured by: Lula Holdings LLC, 15532 St. Charles Avenue, New Orleans, LA, NDC 77348-001-02.
D-0859-2022
Product summary
- Event
- Event 90167
- Status
- Terminated
- Classification
- Class II
- Quantity
- 192.78 pounds
- Official record key
drug-enforcement:D-0859-2022
Official wording
Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
Code information: Batch 39
Distribution pattern: LA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations