Teligent Pharma, Inc. recalls Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes

Recalled March 30, 2022 · FDA recall D-0684-2022 · 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

51,748 tubes

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 Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.

Manufacturer(s)

Teligent Pharma, Inc.

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