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FLUOCINONIDE Recall D-0684-2022

Description: 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.

FLUOCINONIDE Recall D-0684-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0684-2022
Event ID89798
Original Package?1
Active SubstanceFLUOCINONIDE
DistributionNationwide in the USA and Puerto Rico
Quantity51,748 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 NDC52565-054
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 NumberANDA209030
Structured Product Labeling (SPL ID)531184f7-770c-46a4-9bfa-3dbf2a575aa6
Structured Product Labeling (SPL Set ID)2aa35781-40e0-7ce9-45fa-f97333f29085
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