Why it was recalled
Labeling - product contains undeclared ethyl alcohol
Product description
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
Lot numbers, UPCs & expiration codes
Lot#: 39,40,41,42,43,44 and 45
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0635-2022
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 7, 2022
- FDA report date
- Mar 9, 2022
- Quantity
- 1.186.800 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Tsm Brands LLC
Original FDA data
Every field from FDA enforcement report D-0635-2022, exactly as published.
Show all FDA fields
- City
- Manalapan
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 89554
- Address
- 540 Equinox Ln
- Code information
- Lot#: 39,40,41,42,43,44 and 45
- Postal code
- 07726-8877
- Report date
- Mar 9, 2022
- Product type
- Drugs
- Recall number
- D-0635-2022
- Classification
- Class II
- Recalling firm
- Tsm Brands LLC
- Product quantity
- 1.186.800 bottles
- Reason for recall
- Labeling - product contains undeclared ethyl alcohol
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Feb 7, 2022
- Initial firm notification
- Letter
- Center classification date
- Feb 25, 2022