FDA Drug Recalls

Recalls / Class III

Class IIID-0005-2016

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.

Affected lot / code info
Lot #: N0343A, Expiry: 12/12; Lot #: N0344A, Expiry: 12/12.

Why it was recalled

Subpotent Drug: Salicylic acid is subpotent.

Recalling firm

Firm
Guthy-Renker LLC
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
41550 Eclectic St, N/A, Palm Desert, California 92260-1967

Distribution

Quantity
2,537 Compacts
Distribution pattern
U.S. Nationwide including Puerto Rico and Guam; Canada.

Timeline

Recall initiated
2012-05-07
FDA classified
2015-10-01
Posted by FDA
2015-10-07
Terminated
2015-10-02
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0005-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class III recall: drug · FDA Drug Recalls