The Recall Desk

FDA (Drugs) recall action 86105

Real Clean Distribuciones SA de CV recalled 5 products on 2020-09-23

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
2020-09-23
Critical
1
Units
2,487,288

Why these products were recalled

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.

CGMP Deviations: Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Chemical Contamination: 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.

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)··2020-09-23

    Born Basic Hand Sanitizer Recalled for Methanol Contamination

    The FDA is recalling Born Basic Anti-Bac Hand Sanitizer because it contained methanol and had lower ethanol levels than labeled. The recall includes other products from the same manufacturing facility.

    Product
    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
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-09-23

    Scent Theory Hand Sanitizer Recalled for Methanol Contamination

    Scent Theory KEEP IT CLEAN hand sanitizer is being recalled because it was manufactured in a facility where methanol contamination was found.

    Product
    scent theory KEEP IT CLEAN, pure clean,(Ethyl Alcohol 70%), 16.9 FL OZ/500 mL, Distributed by Scent Theory Products, LLC New York, NY 10018, Made in Mexico, UPC 8 40038 21434 1
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2020-09-23

    Born Basic Hand Sanitizer Recalled for Methanol Contamination

    Real Clean Distribuciones SA de CV is recalling Born Basic Anti-Bac Hand Sanitizer because it contained methanol and had lower ethanol levels than labeled.

    Product
    BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3, Made in Mexico; Distributed by Scent Theory Products, LLC, New York, NY 10018.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-09-23

    LUX EOI Hand Sanitizing Gel Recalled for Methanol Contamination

    Real Clean Distribuciones SA de CV is recalling LUX EOI Hand Sanitizing Gel because it contained methanol and was below the label claim for ethanol content.

    Product
    LUX EOI Hand Sanitizing Gel, (Ethyl Alcohol 70%), (16.9 FL OZ) 500mL bottle, Distributed by: Procurement Services, LLC Nashville, TN 37215, Product of Mexico. NDC 74882-007-02
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-09-23

    Scent Theory Hand Sanitizer Recalled for Methanol Contamination

    Scent Theory KEEP CLEAN Moisturizing Hand Sanitizer is being recalled because it contained methanol and fell below the labeled ethanol content.

    Product
    scent theory KEEP CLEAN Moisturizing Hand Sanitizer, 70% alcohol (Ethyl Alcohol 70%), 16.9 FL OZ/500 mL bottle, Distributed by Scent Theory Products, LLC New York, NY 10018. Made in Mexico, UPC 8 40038 21434 1
    Category
    Distribution
    0 states