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
Reason for recall: Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
Recall initiated: 20200928
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated