Multi-event December 2022 FDA Recall Drug by Frenda Corporation

This Multi-event Class II drug recall was voluntarily initiated by Frenda Corporation on December 15, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Puerto Rico and the recall is currently terminated.

Reported Recall Events

D-0259-2023 TERMINATED D-0256-2023 TERMINATED D-0257-2023 TERMINATED D-0260-2023 TERMINATED D-0255-2023 TERMINATED D-0258-2023 TERMINATED D-0254-2023 TERMINATED

Recall Number: D-0259-2023

Reason for Recall
cGMP Deviations
Initiated
12-15-2022
Reported
02-08-2023
Quantity
124 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91325
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.
Frenda Corporation
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.
Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-10-2024
Product Description About Product Description
Full technical description of the product.
Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gallon (128 FL OZ) 3785.41 mL, Dist. by Target Price, Inc. Catano, PR, UPC 8 70373 01326 2

Batch or Lot Expiration Information

Lot# Lot: C013121

Recall Number: D-0256-2023

Reason for Recall
cGMP Deviations
Initiated
12-15-2022
Reported
02-08-2023
Quantity
164 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91325
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.
Frenda Corporation
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.
Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-10-2024
Product Description About Product Description
Full technical description of the product.
Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00054 7

Batch or Lot Expiration Information

Lot# Lot: C030121

Recall Number: D-0257-2023

Reason for Recall
cGMP Deviations
Initiated
12-15-2022
Reported
02-08-2023
Quantity
65,376 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91325
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.
Frenda Corporation
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.
Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-10-2024
Product Description About Product Description
Full technical description of the product.
Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00048 6; b) 16 fl. oz. (473 mL) UPC 8 91857 00047 9, Manufactured by: Frenda Corporation Trujillo Alto, PR 00976

Batch or Lot Expiration Information

Lot# Lots: a)C011721, C011421, C021721, C021521, C021421, C060321, C060221, C042821, C042721, C022521 , C011321; b) C011821, C011721, C052521, C051921, C052421, C030121, C022821

Recall Number: D-0260-2023

Reason for Recall
cGMP Deviations
Initiated
12-15-2022
Reported
02-08-2023
Quantity
12,130 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91325
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.
Frenda Corporation
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.
Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-10-2024
Product Description About Product Description
Full technical description of the product.
Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 mL) UPC 8 70373 01323 1; b) 16 FL OZ (473 mL) UPC 8 70373 01332 3; c) 1 Gallon (128 FL OZ) 3785.41 mL UPC 8 70373 01330 4, Dist. By Target Price, Inc. Catano, PR

Batch or Lot Expiration Information

Lot# Lots: a) C012821, C012721, C021821;b) C012521, C021721; c) C021121, C022121

Recall Number: D-0255-2023

Reason for Recall
cGMP Deviations
Initiated
12-15-2022
Reported
02-08-2023
Quantity
8475 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91325
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.
Frenda Corporation
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.
Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-10-2024
Product Description About Product Description
Full technical description of the product.
Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol, 32 FL. OZ. (946 mL.), Manufactured by: Frenda Corporation Trujilio Alto, PR 00976, UPC 8 91857 00052 3

Batch or Lot Expiration Information

Lot# Lots: C012821, C021421, C022121

Recall Number: D-0258-2023

Reason for Recall
cGMP Deviations
Initiated
12-15-2022
Reported
02-08-2023
Quantity
44,140 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91325
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.
Frenda Corporation
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.
Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-10-2024
Product Description About Product Description
Full technical description of the product.
Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00045 5; b) 16 fl. oz. (473 mL) UPC 8 91857 00055 4; c) Rubbing Alcohol 10 fl. oz. (296 mL) UPC 8 91857 00044 8, Manufactured by Frenda Corporation Trujillo Alto, PR 00976

Batch or Lot Expiration Information

Lot# Lots: a) C030121, C021121, C021021, C030121, C030221, C021721; b) C012721, C012621, C012521, C021721; c) C042721

Recall Number: D-0254-2023

Reason for Recall
cGMP Deviations
Initiated
12-15-2022
Reported
02-08-2023
Quantity
144 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91325
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.
Frenda Corporation
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.
Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-10-2024
Product Description About Product Description
Full technical description of the product.
Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (128 Fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00050 9

Batch or Lot Expiration Information

Lot# Lot: C013121