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FDA Food and Drug Administration : Jaloma

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08/01/2020 | 04:36pm EDT

COMPANY ANNOUNCEMENT

LABORATORIOS JALOMA S.A. de C.V. Issues Voluntary Recall of the Jaloma Antiseptic Hand Sanitizer Due to the Potential Presence of Undeclared Methanol

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary
Company Announcement Date:July 31, 2020FDA Publish Date:August 01, 2020Product Type:Drugs Reason for Announcement:
Recall Reason Description
Undeclared Methanol
Company Name:Laboratorios Jaloma S.A. de C.V. Brand Name:
Brand Name(s)
Jaloma
Product Description:
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)

Toll Free: + 52 1 800 120 0202
Email: asuntosregulatorios@jaloma.com.mx

Consumers should contact their physician or healthcare provider if they experienced any problems that may be related to taking or using this 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.

Company Contact Information
Consumers:LABORATORIOS JALOMA S.A. de C.V. + 52 1 800 120 0202 asuntosregulatorios@jaloma.com.mx
Media:Pedro Morales Rodriguez 52 17221726125
Product Photos

Disclaimer

FDA - Food and Drug Administration published this content on 01 August 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 01 August 2020 20:36:20 UTC

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