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.

Recall Number: D-0685-2022

Firm: Teligent Pharma, Inc.

Classification: Class II

Status: Terminated

Report Date: 20220330

Initiation Date: 20220315

Termination Date: 20240617

Reason for Recall

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

Product Description

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.