Home / Recalls / 4e Brands North America, Llc / D-0022-2021

D-0022-2021 Class II Terminated

Recalled by 4e Brands North America, Llc — San Antonio, TX

Recall Details

Product Type
Drugs
Report Date
October 7, 2020
Initiation Date
July 11, 2020
Termination Date
February 26, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17,359,247 total bottles and pumps

Product Description

blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost with Tea Tree Oil, (70% ethyl alcohol), Packaged as a) 18 fl oz / 532 ml bottle, UPC 8 14266 02408 9 b) 33.8 fl oz / 1L bottle, UPC 8 14266 02374 7, Distributed in USA and Canada BY: 4e Brands Northamerica LLC. 17806 IH-10W, Suite 300, San Antonio, Texas, 78257. Made in Mexico.

Reason for Recall

CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.

Distribution Pattern

Distributed Nationwide in the USA

Code Information

All lots within expiry

Other recalls by 4e Brands North America, Llc

  • D-0030-2021 Class I — blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost wit (July 11, 2020)
  • D-0028-2021 Class II — Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol) (July 11, 2020)
  • D-0024-2021 Class II — blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), (July 11, 2020)
  • D-0029-2021 Class I — blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), (July 11, 2020)
  • D-0025-2021 Class II — blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/v), (July 11, 2020)
  • D-0031-2021 Class I — blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) Pack (July 11, 2020)
  • D-0023-2021 Class II — blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), packag (July 11, 2020)
  • D-0026-2021 Class II — ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packaged (July 11, 2020)
  • D-0027-2021 Class II — ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Package (July 11, 2020)