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FDAMarch 15, 2022drug

Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.

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

The hazard

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

What to do

FDA enforcement status: Terminated

Brands named

teligent pharmateligent

Recall history

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

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Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310. — Recall Details · AllClear