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Class III: unlikely to cause harmTerminated

Guthy-Renker Rodan & Fields Proactiv Solution Recall

Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne…

Guthy-Renker LLC · Palm Desert, CA

Risk level
Class III
Reported by FDA
Oct 7, 2015
Recall ID
D-0004-2016
Check your lot numberHow we source this data

Summary

Guthy-Renker recalled Rodan & Fields Proactiv Solution starting May 7, 2012. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0004-2016 on Oct 7, 2015. Reason: Subpotent Drug: Salicylic acid is subpotent. Status: Terminated.

Why it was recalled

Subpotent Drug: Salicylic acid is subpotent.

Product description

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.

Lot numbers, UPCs & expiration codes

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

Where it was sold

U.S. Nationwide including Puerto Rico and Guam; Canada.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0004-2016
Classification
Class III
Status
Terminated
Recall initiated
May 7, 2012
FDA report date
Oct 7, 2015
Quantity
4,526 Compacts
Recall type
Voluntary: Firm initiated
Recalling firm
Guthy-Renker LLC

Original FDA data

Every field from FDA enforcement report D-0004-2016, exactly as published.

Show all FDA fields
City
Palm Desert
State
CA
Status
Terminated
Country
United States
Event ID
72089
Address
41550 Eclectic St
Code information
Lot #: N0012A, Expiry: 01/12; Lot #: N0257A, Expiry: 09/12; Lot #: N0258A, Expiry: 09/12; Lot #: N0259A, Expiry: 09/12.
Postal code
92260-1967
Report date
Oct 7, 2015
Product type
Drugs
Recall number
D-0004-2016
Classification
Class III
Recalling firm
Guthy-Renker LLC
Product quantity
4,526 Compacts
Termination date
Oct 2, 2015
Reason for recall
Subpotent Drug: Salicylic acid is subpotent.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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.
Distribution pattern
U.S. Nationwide including Puerto Rico and Guam; Canada.
Recall initiation date
May 7, 2012
Initial firm notification
Letter
Center classification date
Oct 1, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0004-2016, published Oct 7, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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