PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacter
Summary
The FDA issued a Class II for PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser by Seatex LLC. Reason: CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility..
Details
Source
Drug Recall
External ID
D-0356-2024
Action Date
2024-03-06
Status
Terminated
Category
drug
Product Description
PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471.
Lot/Code Info: Lot #s: a) 263647, Exp. 06/09/2024; 271382, Exp. 01/18/2025; b) 261675, Exp. 04/09/2024; 263647, Exp. 06/09/2024; 272766, Exp.02/15/2025.
Quantity Affected: 1,450 cases
Reason for Recall
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Distribution
Nationwide in the US and Puerto Rico
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-19
Company
Rosenberg, TX
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 63 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Seatex LLC has 6 FDA actions in our database, including 6 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 (Seatex LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Seatex LLC have FDA actions?
Seatex LLC has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0356-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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