Teligent Pharma, Inc. recalls Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60…

Recall date

September 28, 2020

Source

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

Recall number

D-0064-2021

FDA classification

Class III

Brand / firm

Teligent Pharma, Inc.

Sold / distributed

United States Nationwide

Why it was recalled

Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310