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Class I: serious health riskTerminated

Broncolin, S.A. de C.V. Herbacil Recall

HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a) 4

Broncolin, S.A. de C.V. · Ciudad De Mexico, N/A

Risk level
Class I
Reported by FDA
Sep 23, 2020
Recall ID
D-1578-2020
Check your lot numberHow we source this data

Summary

Broncolin, S.A. de C.V. recalled Herbacil starting Jul 27, 2020. The FDA classified it as Class I (serious health risk) and published enforcement report D-1578-2020 on Sep 23, 2020. Reason: Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below the label claim for ethanol content and contained methanol. Status: Terminated.

Why it was recalled

Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below the label claim for ethanol content and contained 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) 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

Lot# L 201117, Exp 05/2022

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-1578-2020
Classification
Class I
Status
Terminated
Recall initiated
Jul 27, 2020
FDA report date
Sep 23, 2020
Quantity
26,972 bottle
Recall type
Voluntary: Firm initiated
Recalling firm
Broncolin, S.A. de C.V.

Original FDA data

Every field from FDA enforcement report D-1578-2020, 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
Lot# L 201117, Exp 05/2022
Report date
Sep 23, 2020
Product type
Drugs
Recall number
D-1578-2020
Classification
Class I
Recalling firm
Broncolin, S.A. de C.V.
Product quantity
26,972 bottle
Termination date
Aug 7, 2024
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.
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) 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

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1578-2020, published Sep 23, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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