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.
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Chemical Contamination
What was recalled
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60
- Recalling firm
- Novel Laboratories, Inc.
- NDC code
- 43386-069-60
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0653-2017
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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