Fluocinonide Topical Solution USP recalled over manufacturing violations

Recall date

March 15, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Teligent Pharma, Inc. recalls Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20; b) 60 mL bottles, NDC 52565-0…

Recall number

D-0685-2022

FDA classification

Class II

Brand / firm

Teligent Pharma, Inc.

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20; b) 60 mL bottles, NDC 52565-025-59, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.