The Recall Desk

FDA (Drugs) recall action 87941

Global Sanitizers LLC recalled 6 products on 2021-09-08

The FDA (Drugs) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2021-09-08
Critical
0
Units
150,000

Why these products were recalled

CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.

CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot 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.

1–6 of 6

  • SevereFDA (Drugs)··2021-09-08

    MEDICALLY MINDED Hand Sanitizer Gel Recalled for Methanol Contamination

    Global Sanitizers LLC is recalling MEDICALLY MINDED Hand Sanitizer Gel (Ethyl Alcohol 70% v/v, 8.5 FL OZ / 250 mL) distributed nationwide due to manufacturing conditions that led to methanol contamination in product lots.

    Product
    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1 ,
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-09-08

    MEDICALLY MINDED Hand Sanitizer Gel Recalled for Manufacturing Deviations

    Global Sanitizers LLC is recalling MEDICALLY MINDED Hand Sanitizer Gel (70% ethyl alcohol, 8 fl oz bottles) distributed nationwide due to manufacturing deviations under conditions that produced a methanol-contaminated product lot.

    Product
    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 Fl OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200. Distributed by SBL Brands, LLC Las Vegas, NV 89119 UPC: 6
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    0 states
  • SevereFDA (Drugs)··2021-09-08

    Hand Sanitizer Gel Recalled for Methanol Contamination and Low Ethanol

    MEDICALLY MINDED Hand Sanitizer Gel (Ethyl Alcohol 70%) distributed nationwide has been recalled after FDA testing found methanol contamination and ethanol content below label claims. Consumers should stop using the product.

    Product
    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-09-08

    MEDICALLY MINDED Hand Sanitizer Gel recalled for methanol contamination

    The FDA found one lot of MEDICALLY MINDED Hand Sanitizer Gel to contain methanol and fall below the labeled ethanol content. The product was distributed nationwide.

    Product
    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 FL OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made i
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-09-08

    MEDICALLY MINDED Hand Sanitizer Gel Recalled for Methanol Contamination

    Global Sanitizers LLC is recalling MEDICALLY MINDED Hand Sanitizer Gel (8.5 FL OZ) due to potential methanol contamination. The product was manufactured under the same conditions as a lot previously found to contain methanol.

    Product
    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ (250 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Ma
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-09-08

    Hand Sanitizer Gel Recalled Due to Methanol Contamination Risk

    Global Sanitizers LLC is recalling MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel (70% ethyl alcohol) due to manufacturing deviations. Products were made under the same conditions as a lot found to contain methanol.

    Product
    MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL, Manufactured by Grupo V-Klean S.A. de C.V, Calle Alborada 124, Parques del Pedregal, Tlalpan, 14250 Ciudad de Mexico, CDMX, Distributed by SBL Brands, LLC. Las Vegas, NV
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    0 states