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Recall Observatory FDA recall evidence

Drug product

Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-150-04.

D-008-2014

September 08, 2013

Class III

Product summary

Firm
Hill Dermaceuticals, Inc.
Event
Event 66371
Status
Terminated
Classification
Class III
Quantity
Unavailable
Official record key
drug-enforcement:D-008-2014

Official wording

Reason: Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

Code information: K111100 exp.10/13, K111110 exp.10/13, M111240 exp.12/13, and A120012 exp.01/14

Distribution pattern: Nationwide and Puerto Rico.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent