Highest risk U.S. Food and Drug Administration

Jaloma Hand Sanitizer recall: Undeclared Methanol

Recall published 6+ years ago

Undeclared Methanol

Jaloma Prescription & OTC drugs — recalled prescription & otc drugsJaloma Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Jaloma Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)Jaloma Prescription & OTC drugs — recalled prescription & otc drugs (photo 4)
4 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Undeclared allergen or ingredient

An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

What the notice says: 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.

Why it matters: An ingredient that U.S. law requires to be declared is present but missing from the label. People who avoid that ingredient cannot make a safe choice from the packaging.

Symptoms and when to call a doctor

An undeclared allergen is a danger only to people allergic or intolerant to that ingredient. For everyone else the food is safe. Reactions range from an itchy mouth, hives, stomach cramps or vomiting through to anaphylaxis — swelling of the lips, tongue or throat, a tight chest, wheezing, a sudden drop in blood pressure or collapse. If anaphylaxis is suspected, use an epinephrine auto-injector straight away and call 911, even if the symptoms seem to settle, because a second wave can follow hours later.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
July 31, 2020
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Jaloma
Product type
Prescription & OTC drugs
Distribution
Nationwide
UPC codes
759684515033, 759684515026

Products covered by this recall

Hand Sanitizer

What the company announced

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): Jaloma Antiseptic Hand Sanitizer Ethyl Alcohol 62% With vitamin E · NDCs: 65055-600-02 · Sizes: 16.9 fl oz. (1.06 pt) (500 mL) · UPC: 7 59684 51503 3 · Lot #s & Expiration Dates: 0005295 Exp: April, 2022 0006373 Exp: May, 2022
  • Product(s): Jaloma Antiseptic Hand Sanitizer Ethyl Alcohol 62% With vitamin E · NDCs: 65055-600-01 · Sizes: 4 fl oz (120 mL) · UPC: 7 59684 51502 6 · Lot #s & Expiration Dates: 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 : [email protected]

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.

FDA updates on hand sanitizers consumers should not use

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 13 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 759684515033
  • 759684515026

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 0005295
  • 2022 0006373
  • 2022
  • 0005412
  • 2022 0007134
  • 2022 0007834
  • 2022 0009239

Package size

Match the net weight or the piece count on the front of the pack.

  • 500 mL
  • 16.9 fl oz
  • 4 fl oz
  • 120 mL

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Allergen

Jaloma — An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. Report any reaction to the FDA so it is recorded against this recall.
  3. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.
  4. If someone does avoid it, stop serving it and check anything already cooked with it.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Remedy named in the notice: LABORATORIOS JALOMA S.A. de C.V.is arranging for return and refund of all recalled products.

Company contact: Laboratorios Jaloma S.A. de C.V. — Consumers: LABORATORIOS JALOMA S.A. de C.V., + 52 1 800 120 0202, [email protected] — Media: Pedro Morales Rodriguez, 52 17221726125

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Jaloma prescription & otc drugs recalled?

Undeclared Methanol 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 759684515033, 759684515026; best-by date 0005295 or 2022 0006373. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.

Can I get my money back?

The notice says: LABORATORIOS JALOMA S.A. de C.V.is arranging for return and refund of all recalled products.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls