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Safety Report: Optimus Hand Sanitizer - recalled due to Potential Methanol Contamination, USA

4 years ago source fda.gov

Recall notice

United States

Company name: LIQ-E S.A. de C.V.
Brand name: Optimus
Product recalled: Hand Sanitizer
Reason of the recall: Potential Methanol Contamination
FDA Recall date: July 20, 2020
Recall details: 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: Optimus Instant Hand Sanitizer
Product(s) NDCs: 75416-002-01
Sizes: 8.5Fl Oz.(250 mL)
UPC: 7501799115621
Lot #s & Expiration Dates: (L) 20-02 EXP 05/2022

Recalled Products: Optimus Instant Hand Sanitizer
Product(s) NDCs: 75416-001-04
Sizes: 55 Gal (208 L)
UPC: 7501799118998
Lot #s & Expiration Dates: See List

Recalled Products: Optimus Instant Hand Sanitizer
Product(s) NDCs: 75416-378-04
Sizes: 1 GAL (3.78L)
UPC: 7501799118837
Lot #s & Expiration Dates: (L) 20-03 EXP 05/22

Recalled Products: Optimus Instant Hand Sanitizer
Product(s) NDCs: 75416-004-01
Sizes: 275 Gal (1,040 L)
UPC: 7501799118981
Lot #s & Expiration Dates: (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

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/liq-e-sa-de-cv-issues-voluntary-recall-optimus-instant-hand-sanitizer-due-potential-presence

Source: FDA

#drugs #handsanitizer #unitedstates

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