Class II · Moderate risk Ongoing
Fluocinonide
Reason Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Fluocinonide Gel USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
What was recalled
Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.
- Recalling firm
- Teligent Pharma, Inc.
- NDC code
- 52565-054-15
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0684-2022
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 Fluocinonide recalls
See all
Class II · Moderate risk Ongoing
Fluocinonide
Reason Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class II · Moderate risk Ongoing
Fluocinonide
Reason Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class II · Moderate risk Terminated
Fluocinonide Topical Solution USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Fluocinonide Cream USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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