Why it was recalled
CGMP Deviations: products were recalled because they were manufactured in the same facility as the product found to contain methanol.
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
Lot numbers, UPCs & expiration codes
Lots: 201111, 201113, 201115 Exp. 04/30/2022; 201116, 201118, 201119, 201120, 201121, Exp. 05/31/2022,
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1577-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 27, 2020
- FDA report date
- Sep 23, 2020
- Quantity
- 482,416 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Broncolin, S.A. de C.V.
Original FDA data
Every field from FDA enforcement report D-1577-2020, exactly as published.
Show all FDA fields
- City
- Ciudad De Mexico
- Status
- Terminated
- Country
- Mexico
- Event ID
- 86127
- Address
- Calle Sur 16 No. 353
- Address (line 2)
- Col. Agricola Oriental, Iztacalco
- Code information
- Lots: 201111, 201113, 201115 Exp. 04/30/2022; 201116, 201118, 201119, 201120, 201121, Exp. 05/31/2022,
- Report date
- Sep 23, 2020
- Product type
- Drugs
- Recall number
- D-1577-2020
- Classification
- Class II
- Recalling firm
- Broncolin, S.A. de C.V.
- Product quantity
- 482,416 bottles
- Termination date
- Aug 7, 2024
- Reason for recall
- CGMP Deviations: products were recalled because they were manufactured in the same facility as the product found to contain methanol.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jul 27, 2020
- Initial firm notification
- Press Release
- Center classification date
- Sep 11, 2020