FDA Recall D-0635-2022
Tsm Brands LLC · Manalapan, NJ
Class II Ongoing 1557 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
Labeling - product contains undeclared ethyl alcohol
Recall record
- Recall number
D-0635-2022- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- USA Nationwide
- Recall initiated
- 2022-02-07
- Classified by FDA Center
- 2022-02-25
- FDA published
- 2022-03-09
- 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.