Multi-event November 2019 FDA Recall Drug by Idelle Labs

This Multi-event Class III drug recall was voluntarily initiated by Idelle Labs on November 20, 2019 for the product Drug. The FDA reported the reason for recall as labeling product contains undeclared api. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0784-2020 TERMINATED D-0783-2020 TERMINATED D-0785-2020 TERMINATED D-0786-2020 TERMINATED

Recall Number: D-0784-2020

Reason for Recall
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Initiated
11-20-2019
Reported
01-15-2020
Quantity
Unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84620
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Idelle Labs
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-28-2022
Product Description About Product Description
Full technical description of the product.
SURE 48hr Confidence Nourishing Coconut invisible solid Antiperspirant & Deodorant Net Wt 2.6 oz (73g) NDC# 41595-5547-1 UPC 8 83484 31020 5 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912

Batch or Lot Expiration Information

Lot# Lot: 19277K1

Recall Number: D-0783-2020

Reason for Recall
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Initiated
11-20-2019
Reported
01-15-2020
Quantity
Unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84620
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Idelle Labs
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-28-2022
Product Description About Product Description
Full technical description of the product.
SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant, Net Wt. 2.6 oz (73g) NDC# 41595-5509-2 UPC 8 83484 71717 2 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912

Batch or Lot Expiration Information

Lot# Lots: 19273K1, 19274K1, 19274K2, 19725K1, 19725K2, 19726K1

Recall Number: D-0785-2020

Reason for Recall
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Initiated
11-20-2019
Reported
01-15-2020
Quantity
Unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84620
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Idelle Labs
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-28-2022
Product Description About Product Description
Full technical description of the product.
SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5514-1 UPC 8 83484 717936 6 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912

Batch or Lot Expiration Information

Lot# Lots: 19279K1, 19279K2, 19280K1

Recall Number: D-0786-2020

Reason for Recall
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Initiated
11-20-2019
Reported
01-15-2020
Quantity
Unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84620
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Idelle Labs
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-28-2022
Product Description About Product Description
Full technical description of the product.
SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5513-2 UPC 8 83484 71794 3 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912

Batch or Lot Expiration Information

Lot# Lots: 19277K2, 19278K1