HERBACIL recalled over manufacturing violations

Recall date

July 27, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Broncolin, S.A. de C.V. recalls HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a) 4.22 fl. oz. (125ml) bottle, UPC 7 1470…

Recall number

D-1577-2020

FDA classification

Class II

Brand / firm

Broncolin, S.A. de C.V.

Sold / distributed

Distributed Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 14706 91365 5; Made in Mexico by: Broncolin, S.A. de C.V. Sur 16 No. 353, Col. Agricola Oriental, Iztacalco, C.P. 08500, Cuidad de Mexico, Mexico. Importer/Distributor: INBC TRADING LLC 4404 Merle Drive, Austin, TX 78745