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
D-1577-2020
Product summary
- Event
- Event 86127
- Status
- Terminated
- Classification
- Class II
- Quantity
- 482,416 bottles
- Official record key
drug-enforcement:D-1577-2020
Official wording
Reason: CGMP Deviations: products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Code information: Lots: 201111, 201113, 201115 Exp. 04/30/2022; 201116, 201118, 201119, 201120, 201121, Exp. 05/31/2022,
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
found to contain methanol
-
Manufacturing or process control
CGMP Deviations