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.
Fluocinolone Acetonide Topical Oil
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent Drug
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-331-04, UPC 364980331043
Affected NDC
64980-0331-04
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 |
|---|---|---|---|---|
| Fluocinolone Acetonide Oil Fluocinolone Acetonide NDC 64980-0331 |
.11 mg/mL | Oil Topical |
Rising Pharma Holdings, Inc. | Rx |
- Recalling firm
- Lyne Laboratories, Inc.
- NDC code
- 64980-331-04
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0711-2018 · 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
DermOtic Oil
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
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).
Other recalls by Lyne Laboratories, Inc.
All 2018 recalls
Class II · Moderate risk
Fluocinolone Acetonide Topical Oil
Subpotent Drug
Class II · Moderate risk
Fluocinolone Acetonide Topical Oil
Subpotent Drug
Class III · Low risk
Cyproheptadine Hydrochloride Syrup
Subpotency: product assayed and found OOS for cyproheptadine
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