Class III · Low risk
Fluocinolone Acetonide Solution Topical Solution USP
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
DermOtic Oil (Fluocinolone Acetonide)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 for: Royal Pharmaceuticals Manasquan, NJ 08736, NDC 68791-103-20
Affected NDC
68791-0103-20
Compare with the code on your package — it is the most precise check available.
Drug: Fluocinolone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Dermotic fluocinolone acetonide NDC 68791-0103 |
.11 mg/mL | Oil Auricular (otic) |
Royal Pharmaceuticals | Rx |
- Recalling firm
- Hill Dermaceuticals, Inc.
- NDC code
- 68791-103-20
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0637-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Fluocinolone recalls
See all
Class II · Moderate risk
Fluocinolone Acetonide Oil
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Class II · Moderate risk
Formula 82M
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Formula 82F
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Hydroquinone/Fluocinolone/Tretonoin/Kojic Acid 4/0.01/0.05/2% Cream 30 gm tube
Lack of Processing Control
Other recalls by Hill Dermaceuticals, Inc.
All 2021 recalls
Class III · Low risk
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
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.
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