Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ. (1 PT) 355 ML, Distributed by: TSM Brands
Summary
The FDA issued a Class II for Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ. (1 by Tsm Brands LLC. Reason: Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol.
Details
Source
Drug Recall
External ID
D-1475-2022
Action Date
2022-09-07
Status
Ongoing
Category
drug
Product Description
Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ. (1 PT) 355 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965765.
Lot/Code Info: Lot # 015, 016, 017, 018, 018, 019, 020, 021, 022, 023, 024, 025, 026, 027, 028, 029, 030, 031, 032, 033, 034, 035, 036, 037, 038.
Quantity Affected: 350,000 bottles
Reason for Recall
Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
Distribution
Distributed in VA, USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-19
Company
Manalapan, NJ
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 133 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Tsm Brands LLC has 4 FDA actions in our database, including 4 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 (Tsm Brands LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tsm Brands LLC have FDA actions?
Tsm Brands LLC has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1475-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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