Recalls / Class III

Class IIID-0002-2016

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.

Affected lot / code info

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.

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

29,341 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-0002-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.