Teligent Pharma, Inc. recalls Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60
Recalled November 11, 2020 · FDA recall D-0064-2021 · Teligent Pharma
Hazard
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity. · FDA Class III
Units
36,790 tubes
Sold at
United States Nationwide
Description
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
Product
Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: 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 →