Teligent Pharma, Inc. recalls Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams tube, NDC 52565-051-

Recalled March 30, 2022 · FDA recall D-0670-2022 · 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

207,933 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

Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams tube, NDC 52565-051-30; c) 45 grams tube, NDC 52565-051-45; d) 60 grams tube, NDC 52565-051-60; Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

Manufacturer(s)

Teligent Pharma, Inc.

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