Class II · Moderate risk
DermOtic Oil
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
National Drug Code
Is NDC 68791-0103-20 recalled?
Dermotic · 1 BOTTLE, DROPPER in 1 CARTON (68791-103-20) / 20 mL in 1 BOTTLE, DROPPER
Yes — this exact package was recalled
2 FDA recalls name the code 68791-0103-20 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 · Auricular (otic)
- Labeler
- Royal Pharmaceuticals
- Type
- Human Prescription Drug
- Product code
- 68791-0103
Recalls naming this package
Class III · Low risk
ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01%
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
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
- 68791-0101 Derma-Smoothe/FS 1
- 68791-0102 Derma-Smoothe/Fs 1
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