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Recall Observatory FDA recall evidence

Drug 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.

D-0002-2016

May 07, 2012

Class III

Product summary

Firm
Guthy-Renker LLC
Event
Event 72089
Status
Terminated
Classification
Class III
Quantity
29,341 Compacts
Official record key
drug-enforcement:D-0002-2016

Official wording

Reason: Subpotent Drug: Salicylic acid is subpotent.

Code 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.

Distribution pattern: U.S. Nationwide including Puerto Rico and Guam; Canada.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent