D-0859-2022 Class II Terminated
FDA drug recall D-0859-2022 was initiated by Lula Holdings L.L.C. on April 5, 2022 and is designated Class II. Reason for recall: CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits. The recall status is terminated (terminated June 17, 2024). Affected quantity: 192.78 pounds.
Recall Details
- Product Type
- Drugs
- Report Date
- May 18, 2022
- Initiation Date
- April 5, 2022
- Termination Date
- June 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 192.78 pounds
Product Description
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.
Reason for Recall
CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
Distribution Pattern
LA
Code Information
Batch 39