The Recall Desk

FDA (Drugs) recall action 86127

Broncolin, S.A. de C.V. recalled 2 products on 2020-09-23

The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2020-09-23
Critical
1
Units
509,388

Why these products were recalled

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

Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below the label claim for ethanol content and contained 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.

1–2 of 2

  • SevereFDA (Drugs)··2020-09-23

    Broncolin HERBACIL Hand Sanitizer Recalled for Methanol Contamination Risk

    Broncolin is recalling HERBACIL Antiseptic Hand Sanitizer because it was manufactured in the same facility as a product found to contain methanol.

    Product
    HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a) 4.22 fl. oz. (125ml) bottle, UPC 7 14706 91368 6; b) 8.4 fl. oz. (250 ml) bottle, UPC 714706 91367 9; c) 16.9 fl. oz. (500 ml) bottle, UPC 7 14706 91366 2; and d) 33.8 fl. oz. (1 Liter) bottle, UPC 7
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2020-09-23

    Herbacil Hand Sanitizer Recalled for Methanol Contamination and Low Ethanol

    Broncolin, S.A. de C.V. is recalling Herbacil Antiseptic Hand Sanitizer because it contained methanol and had lower ethanol levels than labeled.

    Product
    HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a) 4.22 fl. oz. (125ml) bottle, UPC 7 14706 91368 6; b) 8.4 fl. oz. (250 ml) bottle, UPC 714706 91367 9; c) 33.8 fl. oz. (1 Liter) bottle, UPC 7 14706 91365 5; , Made in Mexico by: Broncolin, S.A. de C.V
    Category
    Distribution
    0 states