Why it was recalled
CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Product description
BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packaged as a) 9.5 FL OZ (280 mL) bottle, UPC 8 40038 21462 4: b) 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3; and c) 34 FL OZ (1L) bottle, UPC 8 40038 21447 1; Made in Mexico; Distributed by Scent Theory Products, LLC, New York, NY 10018.
Lot numbers, UPCs & expiration codes
Lots: a) 0133720, 0233720 b) 0833420, 0933420, 1333420, 1433420, 1533420, 1633420, 1733420, 1833420, 1933420, 2033420, 2133420, 2633420, 2733420, 2833420, 2933420 c) 0133420, 0233420, 0333420, 0433420, 0533420, 0633420
Where it was sold
Distributed Nationwide in the 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-1581-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 23, 2020
- FDA report date
- Sep 23, 2020
- Quantity
- 975,720 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Real Clean Distribuciones SA de CV
Original FDA data
Every field from FDA enforcement report D-1581-2020, exactly as published.
Show all FDA fields
- City
- Tlalnepantla De Baz
- Status
- Terminated
- Country
- Mexico
- Event ID
- 86105
- Address
- Recursos Petroleros
- Address (line 2)
- Fracc Industrial La Loma 3; Tlalnepantla De Baz
- Code information
- Lots: a) 0133720, 0233720 b) 0833420, 0933420, 1333420, 1433420, 1533420, 1633420, 1733420, 1833420, 1933420, 2033420, 2133420, 2633420, 2733420, 2833420, 2933420 c) 0133420, 0233420, 0333420, 0433420, 0533420, 0633420
- Report date
- Sep 23, 2020
- Product type
- Drugs
- Recall number
- D-1581-2020
- Classification
- Class II
- Recalling firm
- Real Clean Distribuciones SA de CV
- Product quantity
- 975,720 bottles
- Termination date
- May 27, 2022
- Reason for recall
- CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packaged as a) 9.5 FL OZ (280 mL) bottle, UPC 8 40038 21462 4: b) 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3; and c) 34 FL OZ (1L) bottle, UPC 8 40038 21447 1; Made in Mexico; Distributed by Scent Theory Products, LLC, New York, NY 10018.
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jul 23, 2020
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 11, 2020