Multi-event July 2020 FDA Recall Drug by Liq-e S.a. De C.v.

This Multi-event Class I drug recall was voluntarily initiated by Liq-e S.a. De C.v. on July 20, 2020 for the product Drug. The FDA reported the reason for recall as chemical contamination. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0254-2021 TERMINATED D-0256-2021 TERMINATED D-0253-2021 TERMINATED D-0255-2021 TERMINATED

Recall Number: D-0254-2021

Reason for Recall
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Initiated
07-20-2020
Reported
02-24-2021
Quantity
575 drums

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86078
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Liq-E S.A. De C.V.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the United States and Mexico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-08-2024
Product Description About Product Description
Full technical description of the product.
OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 55 Gal (208 L) drum, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col.. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477.UPC # 7 501799 118998

Batch or Lot Expiration Information

Lot# L-1160, L-2160, L-3160, L-1180, L-2180, L-2190, Exp. 05/2022; L-1200, L-2200, L-3200, L-4200, L-5200, L-1210 and L-2210, Exp. date 06/2022

Recall Number: D-0256-2021

Reason for Recall
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Initiated
07-20-2020
Reported
02-24-2021
Quantity
1 tank

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86078
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Liq-E S.A. De C.V.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the United States and Mexico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-08-2024
Product Description About Product Description
Full technical description of the product.
OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 275 Gal (1040 L) tank with spout dispenser, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477.; UPC # 7 501799 118981

Batch or Lot Expiration Information

Lot# (L) 5200, exp. date 05/2022

Recall Number: D-0253-2021

Reason for Recall
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Initiated
07-20-2020
Reported
02-24-2021
Quantity
12,201 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86078
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Liq-E S.A. De C.V.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the United States and Mexico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-08-2024
Product Description About Product Description
Full technical description of the product.
OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 8.5 Fl. Oz. (250 mL) bottle, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477. UPC # 7 501799 115621

Batch or Lot Expiration Information

Lot# (L)20-02, exp. date 05/2022

Recall Number: D-0255-2021

Reason for Recall
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Initiated
07-20-2020
Reported
02-24-2021
Quantity
6,597 gallons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86078
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Liq-E S.A. De C.V.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the United States and Mexico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-08-2024
Product Description About Product Description
Full technical description of the product.
OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 1 Gal (3.78 L) bottle, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477; NDC: XXXXX-378-04, UPC # 7 501799 118837

Batch or Lot Expiration Information

Lot# (L) 20-03, exp. date 05/22