FDA Recall D-1583-2020
Real Clean Distribuciones SA de CV · Tlalnepantla De Baz, N/A
Class I — life-threatening Terminated 673 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3, Made in Mexico; Distributed by Scent Theory Products, LLC, New York, NY 10018.
Reason for recall
Chemical Contamination: 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.
Recall record
- Recall number
D-1583-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Distributed Nationwide in the USA
- Recall initiated
- 2020-07-23
- Classified by FDA Center
- 2020-09-11
- FDA published
- 2020-09-23
- Terminated
- 2022-05-27
- Recalling firm
- Real Clean Distribuciones SA de CV
- Firm location
- Tlalnepantla De Baz, N/A, Mexico