D-1583-2020 Class I Terminated

Recalled by Real Clean Distribuciones SA de CV — Tlalnepantla De Baz, N/A

FDA drug recall D-1583-2020 was initiated by Real Clean Distribuciones SA de CV on July 23, 2020 and is designated Class I. 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 fa… The recall status is terminated (terminated May 27, 2022). Affected quantity: N/A.

Recall Details

Product Type
Drugs
Report Date
September 23, 2020
Initiation Date
July 23, 2020
Termination Date
May 27, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

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.

Distribution Pattern

Distributed Nationwide in the USA

Code Information

Lots: 1033420, 1133420, 1233420, 2233420, 2333420, 2433420, 2533420