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FDAFDA · Food and drugs·Recall number D-0685-2022

Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20; b) 60 mL bottles, NDC 52565-025-59, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.

Published March 30, 2022 · Recall initiated: March 15, 2022

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Teligent Pharma, Inc.
Distributor
Nationwide in the USA and Puerto Rico
Lot
Batch: 17138, Exp. 2/28/2023
Risk classification
Class II
Area (FDA)
drug
Country
United States

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