FDA recall D-0859-2022

Lula Holdings L.L.C. · Class II · 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.

Reason for recall

CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.

Distribution

Key facts

Status: Terminated
Initiation date: 2022-04-05
Report date: 2022-05-18
Termination date: 2024-06-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: New Orleans, LA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0859-2022