Home / Recalls / 4e Brands North America, Llc / D-0027-2021

D-0027-2021 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

ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49070 4 b) 10 fL oz / 295 ml bottle, UPC 6 39277 49070 4, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, 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-0022-2021 Class II — blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost wit (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)