Antiseptic Hand Sanitizer Recalled for Undeclared Methanol

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Undeclared Methanol
Company Name:
Laboratorios Jaloma S.A. de C.V.
Brand Name:
Jaloma
Product Description:
Hand Sanitizer

Company Announcement

LABORATORIOS JALOMA S.A. de C.V. is voluntarily recalling all lots and all bottle sizes of the Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% With vitamin E to the consumer level. This recall has been initiated because FDA sampled the 500 mL product and found it to be contaminated with undeclared methanol (wood alcohol). Although the contamination was linked to the 500 mL product, due to the abundance of caution, Jaloma is recalling all lots of all sizes within expiry. The NDCs, lot #s, and expiration dates are listed in the table below.

Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, and permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. To date, LABORATORIOS JALOMA S.A. de C.V. has not received any reports of adverse events related to this recall.

Recalled Products

Product(s)

NDCs

Sizes

UPC

Lot #s & Expiration Dates

Jaloma Antiseptic Hand Sanitizer
Ethyl Alcohol 62%
With vitamin E
65055-600-02 16.9 fl oz.
(1.06 pt) (500 mL)
7 59684 51503 3 0005295
Exp: April, 2022
0006373
Exp: May, 2022
Jaloma Antiseptic Hand Sanitizer
Ethyl Alcohol 62%
With vitamin E
65055-600-01 4 fl oz
(120 mL)
7 59684 51502 6 0005412
Exp: April, 2022
0007134
Exp: May, 2022
0007834
Exp: May, 2022
0009239
Exp: June, 2022

The product is used as a hand sanitizer for hand washing to decrease bacteria on the skin when soap and water are not available. The products are distributed in a 4 fl oz (120 mL) Polyethylene Terephthalate (PET) plastic bottle and a 16.9 fl oz (1.06 pt) (500 mL) PET or High-density polyethylene (HDPE) plastic bottle.  Product is labeled with a red logo with the word Jaloma written in white letters. The product was distributed throughout the United States.  It was imported to one (1) wholesaler and two (2) distributors.

Each product contains a lot number and expiration date stamped directly on the bottle or on the label of the 16.9 fl oz HDPE bottle in the format below.  See table for lot numbers of each individual bottle.

0007834
EXP0522

LABORATORIOS JALOMA S.A. de C.V. is notifying its customers/distributors by recall letter and consumers via this press release. LABORATORIOS JALOMA S.A. de C.V.is arranging for return and refund of all recalled products.

Consumers/distributors/retailers that have the product subject to this recall should stop using/distributing the Jaloma Antiseptic Hand Sanitizer and return it to the place of purchase.

Consumers with questions regarding this recall can contact LABORATORIOS JALOMA S.A. de C.V. during business hours: 9:00am – 5:00pm (CT)

 

Read the full FDA report here.
As published by HealthyExaminer.com

Antiseptic Hand Sanitizer Recalled for Undeclared Methanol

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Undeclared Methanol
Company Name:
Broncolin S.A. de C.V
Brand Name:
Herbacil
Product Description:
Hand Sanitizer

Company Announcement

Broncolin S.A. de C.V is voluntarily recalling all lots of Herbacil Antiseptic Hand Sanitizer 70% Alcohol to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

Risk Statement: Substantial methanol exposure “could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.” To date, Broncolin S.A. de C.V. has not received any reports of adverse events related to the product in question.

The product is an alcohol-based hand sanitizer used to reduce bacteria that potentially cause disease when soap and water are not available and is packaged in 4 bottle sizes; 4.22 fl. oz. (125ml), 8.4 fl. oz. (250 ml), 16.9 fl. oz. (500 ml) and 33.8 fl. oz. (1 Liter). It is a clear plastic bottle with a pump or squeeze cap. All package sizes are labeled with a blue label identifying INBC Trading LLC 4404 Merle Drive, Austin, TX 78745 as the Importer/Distributor (see attachments). Herbacil Antiseptic Hand Sanitizer 70% Alcohol was distributed by the importer/distributor between April 26, 2020 to May 18, 2020 , to wholesalers in Arizona, California, Florida, Georgia, Illinois, Maryland, New Jersey, New York, North Carolina, South Carolina, and Texas and further distributed Nationwide in the USA.

Broncolin S.A. de C.V via INBC Trading LLC is notifying all US customers by email and is arranging for the return of all recalled products. Consumers, distributors, and retailers that have recalled Herbacil hand sanitizer, should stop using and return to the place of purchase.

Any questions regarding this recall can be directed to INBC Trading LLC at 1-512-241-9034 and/or [email protected], Monday-Friday, 8:00 am-5 pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Read the full FDA report here.
As published by HealthyExaminer.com

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