Product Safety Recalls

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FLUOCINONIDE Recall D-0683-2022

Description: Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-079-11.

FLUOCINONIDE Recall D-0683-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0683-2022
Event ID89798
BrandFLUOCINONIDE
Generic NameFLUOCINONIDE
ManufacturerFLUOCINONIDE
Original Package?1
Active SubstanceFLUOCINONIDE
Drug RouteTOPICAL
DistributionNationwide in the USA and Puerto Rico
Quantity13,905 tubes
Recall ReasoncGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Drug ClassificationClass II
Drug Code Info20220330
Product NDC52565-079
Product NUIN0000175576 N0000175450
Pharma Class (EPC)Corticosteroid [EPC]
Recall Initiation Date20220315
Report Date20220330
Classification Date20220321
Address105 Lincoln Avenue
Buena, NJ 08310
United States
Recalling FirmTeligent Pharma, Inc.
Initial Notification Letter
Unique Ingredient Identifier2W4A77YPAN
Drug Application NumberANDA211758
Structured Product Labeling (SPL ID)285c6180-cee8-4878-9e76-e8bb321c1af8
Structured Product Labeling (SPL Set ID)43770897-5784-4817-9fb1-7057b5447d5c
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