The Recall Desk

FDA (Drugs) recall action 86162

Albek De Mexico S.A. De C.V. recalled 5 products on 2020-11-25

The FDA (Drugs) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2020-11-25
Critical
0
Units
6,090,088

Why these products were recalled

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–5 of 5

  • SevereFDA (Drugs)··2020-11-25

    Hand Sanitizer Recalled for Methanol Contamination and Low Ethanol Content

    Albek De Mexico is recalling Assured Instant Hand Sanitizer bottles because they contained methanol and had lower ethanol levels than labeled.

    Product
    Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 fl oz/ 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico, UPC 639277928597
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-11-25

    Hand Sanitizer Recalled for Methanol Contamination and Low Ethanol Content

    Albek De Mexico S.A. De C.V. is recalling Modesa Instant Hand Sanitizer because it contained methanol and had lower ethanol content than labeled.

    Product
    Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol 70% v/v) 8 fl oz (237 mL) bottle, Distributed by: Midwood brands, LLC 10611 Monroe RD. Mathews, NC 28105 Made in Mexico UPC 3 2251 38042 6
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-11-25

    Next Advanced Antibacterial Hand Sanitizer Recalled for Methanol Contamination

    Albek De Mexico S.A. De C.V. is recalling Next Advanced Antibacterial Hand Sanitizer because it contained methanol and had lower ethanol levels than labeled.

    Product
    NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ML) bottle, Made in Mexico, Distributed by: Genomma Lab USA Inc., Houston, TX 77027. UPC 6 50240 05357 3
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-11-25

    Assured Instant Hand Sanitizer Recalled for Methanol Contamination

    Albek De Mexico S.A. De C.V. is recalling 27,000 bottles of Assured Instant Hand Sanitizer because the product contained methanol and was below the label claim for ethanol content.

    Product
    Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico.UPC 639277928610
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-11-25

    Hand Sanitizer Recalled for Methanol Contamination and Low Ethanol Content

    Albek De Mexico S.A. De C.V. is recalling NuuxSan hand sanitizer because it contained methanol and had lower ethanol levels than labeled.

    Product
    NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl oz. 237 mL bottle, Distributed by PCM North America LLC 9543 Bassonnet ST. STE 307, Houston, TX 77036, Made in Mexico, UPC 7 13620 00017 5
    Category
    Distribution
    0 states