HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a) 4.22 fl. oz. (125...

FDA Drug Recall #D-1578-2020 — Class I — July 27, 2020

Recall Summary

Recall Number D-1578-2020
Classification Class I — Serious risk
Date Initiated July 27, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Broncolin, S.A. de C.V.
Location Ciudad De Mexico, N/A
Product Type Drugs
Quantity 26,972 bottle

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) 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.

Distribution Pattern

Distributed Nationwide in the USA

Lot / Code Information

Lot# L 201117, Exp 05/2022

Other Recalls from Broncolin, S.A. de C.V.

Recall # Classification Product Date
D-1577-2020 Class II HERBACIL, Antiseptic Hand Sanitizer, 70% Alcoho... Jul 27, 2020

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.