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
D-0635-2022
Product summary
- Firm
- Tsm Brands LLC
- Event
- Event 89554
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1.186.800 bottles
- Official record key
drug-enforcement:D-0635-2022
Official wording
Reason: Labeling - product contains undeclared ethyl alcohol
Code information: Lot#: 39,40,41,42,43,44 and 45
Distribution pattern: USA Nationwide
Derived failure modes
-
Unknown
Labeling - product contains undeclared ethyl alcohol