Class III · Low risk Ongoing
Fluocinolone Acetonide Solution Topical Solution USP
Reason Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01%
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
What was recalled
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals for: Royal Pharmaceuticals NDC 68791-102-04
- Recalling firm
- Hill Dermaceuticals, Inc.
- NDC code
- 68791-102-04
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1177-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Fluocinolone recalls
See all
Class II · Moderate risk Terminated
Fluocinolone Acetonide Oil
Reason Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Class II · Moderate risk Terminated
DermOtic Oil
Reason Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Class II · Moderate risk Terminated
Formula 82M
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Formula 82F
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
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