Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04

FDA recall notice · announced April 3, 2013 · Hill Dermaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04

Reason for recall

Subpotent; 22 month stability timepoint

Notes

Distribution: Nationwide
Lot/code information: Lot # D110550, Exp. 04/2013.
Quantity: 8,592 bottles
Status: Terminated
Products in this recall event:
- Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04 (D-217-2013)
- Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceut (D-218-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.