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TRIAMCINOLONE ACETONIDE Recall D-0697-2022

Description: Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-056-15; b) 30 grams tubes, NDC 52565-056-30; c) 80 grams tubes, NDC 52565-056-80, d) 1 lb (454 g) jars, NDC 52565-056-26; Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.

TRIAMCINOLONE ACETONIDE Recall D-0697-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0697-2022
Event ID89798
BrandTRIAMCINOLONE ACETONIDE
Generic NameTRIAMCINOLONE ACETONIDE
ManufacturerTRIAMCINOLONE ACETONIDE
Original Package?1
Active SubstanceTRIAMCINOLONE ACETONIDE
Drug RouteTOPICAL
DistributionNationwide in the USA and Puerto Rico
Quantity721,225 tubes; 90,893 jars
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 NDC52565-056
Product NUIN0000175576 N0000175450
Drug UPC0352565056153 0352565056269
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 IdentifierF446C597KA
Drug Application NumberANDA208848
Structured Product Labeling (SPL ID)68429a04-764e-44ec-8359-0050d9dd5544
Structured Product Labeling (SPL Set ID)f660c29d-1a39-32e8-567e-ed6dd96fde8d
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