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 52565-02

Recalled March 30, 2022 · FDA recall D-0685-2022 · Teligent Pharma

Hazard

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

Units

7169 bottles

Sold at

Nationwide in the USA and Puerto Rico

Description

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

Product

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.

Manufacturer(s)

Teligent Pharma, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →