FDA-Drug2020-11-11Class III
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
Teligent Pharma, Inc.
Hazard
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
Sold states
United States Nationwide
Affected count
36,790 tubes
Manufactured in
105 Lincoln Avenue, N/A, Buena, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0064-2021Don't want to check this manually?
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