FDA Recall D-1578-2020
Broncolin, S.A. de C.V. · Ciudad De Mexico, N/A
Class I — life-threatening Terminated 1472 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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. 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
Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below the label claim for ethanol content and contained methanol.
Recall record
- Recall number
D-1578-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Distributed Nationwide in the USA
- Recall initiated
- 2020-07-27
- Classified by FDA Center
- 2020-09-11
- FDA published
- 2020-09-23
- Terminated
- 2024-08-07
- Recalling firm
- Broncolin, S.A. de C.V.
- Firm location
- Ciudad De Mexico, N/A, Mexico