Product Safety Recalls

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TRIAMCINOLONE ACETONIDE Recall D-1497-2022

Description: Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36.

TRIAMCINOLONE ACETONIDE Recall D-1497-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1497-2022
Event ID90790
BrandTRIAMCINOLONE ACETONIDE
Generic NameTRIAMCINOLONE ACETONIDE
ManufacturerTRIAMCINOLONE ACETONIDE
Original Package?1
Active SubstanceTRIAMCINOLONE ACETONIDE
Drug RouteTOPICAL
DistributionNationwide in the USA
Quantity57,816 tubes
Recall ReasonCGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Drug ClassificationClass II
Drug Code Info20220907
Product NDC45802-063 45802-064 45802-065
Product NUIN0000175576 N0000175450
Pharma Class (EPC)Corticosteroid [EPC]
Recall Initiation Date20220817
Report Date20220907
Classification Date20220907
Address3940 Quebec Ave N
Minneapolis, MN 55427-1244
United States
Recalling FirmPadagis US LLC
Initial Notification Letter
Unique Ingredient IdentifierF446C597KA
Drug Application NumberANDA086413
Structured Product Labeling (SPL ID)011704cc-50e1-42e1-9e4d-96d36b838c1f
Structured Product Labeling (SPL Set ID)5d2fe6c2-3856-47f6-843f-077b2e1080a0
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