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

Recall Number: D-0683-2022

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