D-1577-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 23, 2020
- Initiation Date
- July 27, 2020
- Termination Date
- August 7, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 482,416 bottles
Product Description
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 Pattern
Distributed Nationwide in the USA
Code Information
Lots: 201111, 201113, 201115 Exp. 04/30/2022; 201116, 201118, 201119, 201120, 201121, Exp. 05/31/2022,