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FDASeptember 28, 2020drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.

What to do

FDA enforcement status: Terminated

Brands named

teligent pharmateligent

UPCs

525650040155256500403052565004060

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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