Multi-event May 2012 FDA Recall Drug by Guthy-renker Llc

This Multi-event Class III drug recall was voluntarily initiated by Guthy-renker Llc on May 7, 2012 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0002-2016 TERMINATED D-0003-2016 TERMINATED D-0004-2016 TERMINATED D-0005-2016 TERMINATED D-0001-2016 TERMINATED

Recall Number: D-0002-2016

Reason for Recall
Subpotent Drug: Salicylic acid is subpotent.
Initiated
05-07-2012
Reported
10-07-2015
Quantity
29,341 Compacts

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72089
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.
Guthy-Renker LLC
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.
U.S. Nationwide including Puerto Rico and Guam; Canada.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-02-2015
Product Description About Product Description
Full technical description of the product.
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, LIGHT, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.

Batch or Lot Expiration Information

Lot# : N0054A, Expiry: 02/12
Lot# : N0055A, Expiry: 02/12
Lot# : N0201A, Expiry: 07/12
Lot# : N0202A, Expiry: 07/12
Lot# : N0351A, Expiry: 12/12
Lot# : N0354A, 12/12
Lot# : N0355A, Expiry: 12/12
Lot# : N1033A, Expiry: 02/13
Lot# : N1046A, Expiry: 02/13
Lot# : N1108A, Expiry: 04/13
Lot# : N1291A, Expiry: 10/13
Lot# : N1319A, Expiry: 11/13
Lot# : N1320A, Expiry: 11/13.

Recall Number: D-0003-2016

Reason for Recall
Subpotent Drug: Salicylic acid is subpotent.
Initiated
05-07-2012
Reported
10-07-2015
Quantity
5,025 Compacts

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72089
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.
Guthy-Renker LLC
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.
U.S. Nationwide including Puerto Rico and Guam; Canada.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-02-2015
Product Description About Product Description
Full technical description of the product.
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, MEDIUM, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.

Batch or Lot Expiration Information

Lot# : N0211A, Expiry: 07/12
Lot# : N0214A, Expiry: 08/12
Lot# : N0284A, Expiry: 10/12
Lot# : N0285A, Expiry: 10/12
Lot# : N0286A, Expiry: 10/12.

Recall Number: D-0004-2016

Reason for Recall
Subpotent Drug: Salicylic acid is subpotent.
Initiated
05-07-2012
Reported
10-07-2015
Quantity
4,526 Compacts

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72089
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.
Guthy-Renker LLC
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.
U.S. Nationwide including Puerto Rico and Guam; Canada.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-02-2015
Product Description About Product Description
Full technical description of the product.
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, TAN, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.

Batch or Lot Expiration Information

Lot# : N0012A, Expiry: 01/12
Lot# : N0257A, Expiry: 09/12
Lot# : N0258A, Expiry: 09/12
Lot# : N0259A, Expiry: 09/12.

Recall Number: D-0005-2016

Reason for Recall
Subpotent Drug: Salicylic acid is subpotent.
Initiated
05-07-2012
Reported
10-07-2015
Quantity
2,537 Compacts

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72089
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.
Guthy-Renker LLC
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.
U.S. Nationwide including Puerto Rico and Guam; Canada.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-02-2015
Product Description About Product Description
Full technical description of the product.
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, DARK, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.

Batch or Lot Expiration Information

Lot# : N0343A, Expiry: 12/12
Lot# : N0344A, Expiry: 12/12.

Recall Number: D-0001-2016

Reason for Recall
Subpotent Drug: Salicylic acid is subpotent.
Initiated
05-07-2012
Reported
10-07-2015
Quantity
9,960 Compacts

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72089
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.
Guthy-Renker LLC
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.
U.S. Nationwide including Puerto Rico and Guam; Canada.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-02-2015
Product Description About Product Description
Full technical description of the product.
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, FAIR, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.

Batch or Lot Expiration Information

Lot# : N0362A, Expiry: 12/12
Lot# : N0363A, Expiry: 12/12
Lot# : N1264A, Expiry: 09/13
Lot# : N1265A; Expiry: 09/13.