Kill 'Dat Sanitizing Products Hand Sanitizer, 1 gallon (128 fl. oz.) 80% Alcohol, OTC, Manufactured by: Lula Holdings L
Summary
The FDA issued a Class II for Kill 'Dat Sanitizing Products Hand Sanitizer, 1 gallon (128 fl. oz.) 80% Alcohol by Lula Holdings L.L.C.. Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits..
Details
Source
Drug Recall
External ID
D-0859-2022
Action Date
2022-05-18
Status
Terminated
Category
drug
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.
Lot/Code Info: Batch 39
Quantity Affected: 192.78 pounds
Reason for Recall
CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
Distribution
LA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-05
Company
New Orleans, LA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Lula Holdings L.L.C.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lula Holdings L.L.C. have FDA actions?
This is the only FDA action we have on record for Lula Holdings L.L.C. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0859-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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