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- Recall Enforcement Event ID: 86858
Recall Enforment Report D-0161-2021
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Simex Logistics SA de CV, originally initiated on 11-25-2020 for 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 The product was recalled due to subpotent drug. The product was distributed in Ca, Ga, Nv, Tx and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0161-2021 | 11-25-2020 | 12-23-2020 | Class II | 1800 bottles | 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 | Subpotent drug | Terminated |
| D-0164-2021 | 11-25-2020 | 12-23-2020 | Class II | 38016 bottles | 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 | Subpotent drug | Terminated |
| D-0163-2021 | 11-25-2020 | 12-23-2020 | Class II | 16308 bottles | 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 | Subpotent drug | Terminated |
| D-0160-2021 | 11-25-2020 | 12-23-2020 | Class II | 19340 bottles | +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. | Subpotent drug | Terminated |
| D-0162-2021 | 11-25-2020 | 12-23-2020 | Class II | 19008 bottles | 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 | Subpotent drug | Terminated |
Recall Enforcement Report D-0161-2021
- Event ID
- 86858 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0161-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- CA, GA, NV, TX What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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
- Reason For Recall
- Subpotent drug What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1800 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 12-23-2020
- Recall Initiation Date
- 11-25-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-17-2023 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Simex Logistics SA de CV
- Code Info
- Lot: 0-620, Exp 06/10/2023 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0164-2021
- Event ID
- 86858 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0164-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- CA, GA, NV, TX What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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
- Reason For Recall
- Subpotent drug What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 38016 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 12-23-2020
- Recall Initiation Date
- 11-25-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-17-2023 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Simex Logistics SA de CV
- Code Info
- Lot: 0-520, Exp 05/26/2023 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0163-2021
- Event ID
- 86858 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0163-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- CA, GA, NV, TX What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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
- Reason For Recall
- Subpotent drug What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 16308 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 12-23-2020
- Recall Initiation Date
- 11-25-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-17-2023 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Simex Logistics SA de CV
- Code Info
- Lot: 0-620, Exp 08/05/2023 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0160-2021
- Event ID
- 86858 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0160-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- CA, GA, NV, TX What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- +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.
- Reason For Recall
- Subpotent drug What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 19340 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 12-23-2020
- Recall Initiation Date
- 11-25-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-17-2023 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Simex Logistics SA de CV
- Code Info
- Lot: 0-820, Exp 07/13/2023 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0162-2021
- Event ID
- 86858 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0162-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- CA, GA, NV, TX What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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
- Reason For Recall
- Subpotent drug What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 19008 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 12-23-2020
- Recall Initiation Date
- 11-25-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-17-2023 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Simex Logistics SA de CV
- Code Info
- Lot: 0-720, Exp 05/16/2023 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
