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Recall Observatory FDA recall evidence

Drug product

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.

D-1475-2022

July 19, 2022

Class II

Product summary

Firm
Tsm Brands LLC
Event
Event 90619
Status
Ongoing
Classification
Class II
Quantity
350,000 bottles
Official record key
drug-enforcement:D-1475-2022

Official wording

Reason: Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol

Code information: 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.

Distribution pattern: Distributed in VA, USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol