FDA recall D-1577-2020

Broncolin, S.A. de C.V. · Class II · drug

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 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

Reason for recall

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

Distribution

Distributed Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2020-07-27
Report date: 2020-09-23
Termination date: 2024-08-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Ciudad De Mexico, N/A, Mexico

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1577-2020