Multi-event November 2020 FDA Recall Drug by Simex Logistics Sa De Cv

This Multi-event Class II drug recall was voluntarily initiated by Simex Logistics Sa De Cv on November 25, 2020 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed in CA, GA, NV, TX and the recall is currently terminated.

Reported Recall Events

D-0161-2021 TERMINATED D-0164-2021 TERMINATED D-0163-2021 TERMINATED D-0160-2021 TERMINATED D-0162-2021 TERMINATED

Recall Number: D-0161-2021

Reason for Recall
Subpotent drug
Initiated
11-25-2020
Reported
12-23-2020
Quantity
1800 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86858
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Simex Logistics SA de CV
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA, GA, NV, TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-17-2023
Product Description About Product Description
Full technical description of the product.
CitruGel Hand Sanitizer Advanced Formula 70% Alcohol Fresh Lemon Scent, 33.81 FL OZ (1L), Distributed By Citru Gel Inc. Henderson, NV 89052 www.citrugel.com NDC: 78247-002-01

Batch or Lot Expiration Information

Lot# Lot: 0-620, Exp 06/10/2023

Recall Number: D-0164-2021

Reason for Recall
Subpotent drug
Initiated
11-25-2020
Reported
12-23-2020
Quantity
38016 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86858
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Simex Logistics SA de CV
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA, GA, NV, TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-17-2023
Product Description About Product Description
Full technical description of the product.
Lavar 70 Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distributed By Blue Ridge Southern Supply, LLC. 1130 Aba St. Blue Ridge, GA 30513 Produced By: Simex Logistics S.A. de C.V Salvatierra No. 101 Fraccionamiento El Puente Celaya, Guanajuato, Mexico, Barcode: 7 05333 5897

Batch or Lot Expiration Information

Lot# Lot: 0-520, Exp 05/26/2023

Recall Number: D-0163-2021

Reason for Recall
Subpotent drug
Initiated
11-25-2020
Reported
12-23-2020
Quantity
16308 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86858
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Simex Logistics SA de CV
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA, GA, NV, TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-17-2023
Product Description About Product Description
Full technical description of the product.
UVT World Gel Hand Sanitizer 70% Alcohol Content, 33.9 FL OZ (1LT), Distributed By UVT World Newport Beach, CA 92660 www.uvt.world Produced By: Simex Logistics S.A. de C.V. Salvatierra No. 101 Fraccionamiento El Puente Celaya, Guanajuato, Mexico Barcode: 7 00306 88677 2

Batch or Lot Expiration Information

Lot# Lot: 0-620, Exp 08/05/2023

Recall Number: D-0160-2021

Reason for Recall
Subpotent drug
Initiated
11-25-2020
Reported
12-23-2020
Quantity
19340 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86858
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Simex Logistics SA de CV
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA, GA, NV, TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-17-2023
Product Description About Product Description
Full technical description of the product.
+Protec Hands Antibacterial Gel Topical Solution Instant Sanitizer Hands 70% Alcohol Antiseptic, packaged in bottles of a) 33.8 Oz (1000mL) Barcode: GOOD-GEL-04062020L; b) 127.8 oz (3780mL) Barcode 0723707893163, Distributed by: PS Promotional Services LLC Allen Street #406 Dallas, Texas 75204 Produced By: Simex Logistics S.A. de C.V. Salvatierra No. 101 Fraccionamiento El Puente. Celaya, Guanajuato, Mexico.

Batch or Lot Expiration Information

Lot# Lot: 0-820, Exp 07/13/2023

Recall Number: D-0162-2021

Reason for Recall
Subpotent drug
Initiated
11-25-2020
Reported
12-23-2020
Quantity
19008 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86858
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Simex Logistics SA de CV
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA, GA, NV, TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-17-2023
Product Description About Product Description
Full technical description of the product.
Health & Hand Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distributed By Blue Ridge Southern Supply, LLC 1130 Ada St. Blue Ridge, GA 30513 Produced By: Simex Logistics S.A. de C.V. Salvatierra No. 101 Fracc. El Puente C.P. 38040 Celaya, Guanajuato, Mexico. [email protected] Barcode: 6 18149 21988 9

Batch or Lot Expiration Information

Lot# Lot: 0-720, Exp 05/16/2023