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

Recall Number: D-0064-2021

Firm: Teligent Pharma, Inc.

Classification: Class III

Status: Terminated

Report Date: 20201111

Initiation Date: 20200928

Termination Date: 20220822

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

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