FDA Recall D-1475-2022

Tsm Brands LLC · Manalapan, NJ

Class II Ongoing 1395 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: 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: 350,000 bottles

Reason for recall

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

Recall record

Recall number: D-1475-2022
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed in VA, USA
Recall initiated: 2022-07-19
Classified by FDA Center: 2022-08-31
FDA published: 2022-09-07
Recalling firm: Tsm Brands LLC
Firm location: Manalapan, NJ

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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