Home / Recalls / Real Clean Distribuciones SA de CV / D-1581-2020

D-1581-2020 Class II Terminated

Recalled by Real Clean Distribuciones SA de CV — Tlalnepantla De Baz, 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
975,720 bottles

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.

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.

Distribution Pattern

Distributed Nationwide in the USA

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

Other recalls by Real Clean Distribuciones SA de CV

  • D-1582-2020 Class II — LUX EOI Hand Sanitizing Gel, (Ethyl Alcohol 70%), (16.9 FL OZ) 500mL bottle, Dis (July 23, 2020)
  • D-1579-2020 Class II — scent theory KEEP IT CLEAN, pure clean,(Ethyl Alcohol 70%), 16.9 FL OZ/500 mL, D (July 23, 2020)
  • D-1583-2020 Class I — BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), 16.9 FL (July 23, 2020)
  • D-1580-2020 Class II — scent theory KEEP CLEAN Moisturizing Hand Sanitizer, 70% alcohol (Ethyl Alcohol (July 23, 2020)