Class III · Low risk
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01%
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
National Drug Code
Is NDC 68791-0102-04 recalled?
Derma-Smoothe/Fs · 1 BOTTLE in 1 CARTON (68791-102-04) / 118.28 mL in 1 BOTTLE
Yes — this exact package was recalled
1 FDA recall names the code 68791-0102-04 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- fluocinolone acetonide
- Strength
- FLUOCINOLONE ACETONIDE .11 mg/mL
- Form
- Oil · Topical
- Labeler
- Royal Pharmaceuticals
- Type
- Human Prescription Drug
- Product code
- 68791-0102
Recalls naming this package
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 68791-0103 Dermotic 2
- 68791-0101 Derma-Smoothe/FS 1
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