LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker Compa
Summary
The FDA issued a Class II for LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per by Neogen Corporation. Reason: CGMP violations..
Details
Source
Drug Recall
External ID
D-0073-2025
Action Date
2024-12-04
Status
Ongoing
Category
drug
Product Description
LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53427-124-01
Lot/Code Info: Lot LO09530; Exp 9/5/2025
Quantity Affected: 5,328 sachets
Reason for Recall
CGMP violations.
Distribution
Product sold directly to one distributor consignee, Bob Barker Company, an American company that sells supplies to prisons, jails, and other institutions.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-08
Company
Lexington, KY
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 55 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Neogen Corporation has 2 FDA actions in our database, including 2 recalls.
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 (Neogen Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Neogen Corporation have FDA actions?
Neogen Corporation has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0073-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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