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Recall Observatory FDA recall evidence

Drug product

Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.

D-0636-2022

February 07, 2022

Class II

Product summary

Firm
Tsm Brands LLC
Event
Event 89554
Status
Ongoing
Classification
Class II
Quantity
135.444 bottles
Official record key
drug-enforcement:D-0636-2022

Official wording

Reason: Labeling - product contains undeclared ethyl alcohol

Code information: Lot#:339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379,380,381,382,383,384,385,386,387,388,389,390,391,392,393,394,395,396,397,398 and 399

Distribution pattern: USA Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling - product contains undeclared ethyl alcohol