Why it was recalled
Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
Product description
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 numbers, UPCs & expiration codes
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.
Where it was sold
Distributed in VA, USA
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-1475-2022
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 19, 2022
- FDA report date
- Sep 7, 2022
- Quantity
- 350,000 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Tsm Brands LLC
Original FDA data
Every field from FDA enforcement report D-1475-2022, exactly as published.
Show all FDA fields
- City
- Manalapan
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 90619
- Address
- 540 Equinox Ln
- 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.
- Postal code
- 07726-8877
- Report date
- Sep 7, 2022
- Product type
- Drugs
- Recall number
- D-1475-2022
- Classification
- Class II
- Recalling firm
- Tsm Brands LLC
- Product quantity
- 350,000 bottles
- Reason for recall
- Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Distributed in VA, USA
- Recall initiation date
- Jul 19, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 31, 2022