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