Summary

Company Announcement Date:
July 20, 2020
FDA Publish Date:
July 20, 2020
Product Type:
Drugs
Reason for Announcement:

Recall Reason Description

Potential Methanol Contamination

Company Name:
LIQ-E S.A. de C.V.
Brand Name:

Brand Name(s)

Product Description:

Product Description

Hand Sanitizer


Company Announcement

SAN NICOLAS DE LOS GARZA, Mexico — LIQ-E S.A. de C.V. is voluntarily recalling all lots and all bottle sizes of The OPTIMUS Instant Hand Sanitizer due to the potential presence of methanol (wood alcohol) that were shipped into the United States. The products were manufactured between April 27, 2020 and May 08, 2020.

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, LIQ-E 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
Optimus Instant Hand Sanitizer 75416-002-01 8.5Fl Oz.(250 mL) 7501799115621 (L) 20-02 EXP 05/2022
Optimus Instant Hand Sanitizer 75416-001-04 55 Gal (208 L) 7501799118998 See List
Optimus Instant Hand Sanitizer 75416-378-04 1 GAL (3.78L) 7501799118837 (L) 20-03 EXP 05/22
Optimus Instant Hand Sanitizer 75416-004-01 275 Gal (1,040 L) 7501799118981 (L) 5200 EXP 05/2022

55 Gal Blue Drum Lot Numbers:

L-1160 EXP 05/2022 L-2160 EXP 05/2022 L-3160 EXP 05/2022 L-1180 EXP 05/2022 L-2180 EXP 05/2022 L-2190 EXP 05/2022
L-1200 EXP 06/2022 L-2200 EXP 06/2022 L-3200 EXP 06/2022 L-4200 EXP 06/2022 L-5200 EXP 06/2022 L-1210 EXP 06/2022 L-2210 EXP 06/2022

Master Cartons Lot Numbers,

L-1150 L-2150 L-3150 L-4150 L-5150 L-6150
L-1160 L-2160 L-3160 L-4160 L-5160 L-6160
L-1170 L-2170 L-3170 L-4170 L-5170 L-1180
L-3180 L-4180 L-6180 L-1190 L-2190 L-3190
L-4190 L-5190 L-6190 L-1200 L-2200 L-3200
L-4200 L-5200 L-6200 L-2180

The Hand Sanitizer is distributed in a 55 Gal (208 L) plastic blue drum and in 8.5Fl Oz. (250 mL), 1Gal (3.78 L), and 275 Gal (1,040L) clear plastic HDPE bottles or tank. All are labeled with a green and white label. The product was distributed throughout the United States.

Each product contains a lot number consisting of a letter followed by a dash four digits (example L-1180). This number can be found on the master cartons and written in black pen on the 55 Gal blue drum and the 275 Gal plastic tank.

The individual bottles are labeled with a lot number and expiration date in the format below. See table for lot numbers of each individual bottle.

(L) 20-02 EXP 05/2022

LIQ-E S.A. de C.V. is notifying its customers/distributors by recall letter and consumers via this press release. LIQ-E S.A. de C.V. is arranging for return and refund, if it is the case, of all recalled products.

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

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

Toll Free: 5281 81316021
FAX: 5281 81316018
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.


Company Contact Information

Media:
Ignacio Ortiz
5281 81316021

Product Photos