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Recall Observatory FDA recall evidence

Drug 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.

D-0005-2016

May 07, 2012

Class III

Product summary

Firm
Guthy-Renker LLC
Event
Event 72089
Status
Terminated
Classification
Class III
Quantity
2,537 Compacts
Official record key
drug-enforcement:D-0005-2016

Official wording

Reason: Subpotent Drug: Salicylic acid is subpotent.

Code information: Lot #: N0343A, Expiry: 12/12; Lot #: N0344A, Expiry: 12/12.

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