FDA recall D-0635-2022

Tsm Brands LLC · Class II · drug

Product

70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle, Distributed By: TSM Brands LLC, 540 Equinox LN, Manalapan, NJ 07726, www.tsmbrands.com, Made in Turkey, UPC 868275965765

Reason for recall

Labeling - product contains undeclared ethyl alcohol

Distribution

USA Nationwide

Key facts

Status
Ongoing
Initiation date
2022-02-07
Report date
2022-03-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Manalapan, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0635-2022