US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 15, 2022 (4 years ago)

Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma…

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 Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-079-11.

Recalling firm
Teligent Pharma, Inc.
NDC code
52565-079-11
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0683-2022

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.

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