Product Safety Recalls

Product Recall Tracker

TRIAMCINOLONE ACETONIDE Recall D-1535-2022

Description: Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.

TRIAMCINOLONE ACETONIDE Recall D-1535-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1535-2022
Event ID90869
BrandTRIAMCINOLONE ACETONIDE
Generic NameTRIAMCINOLONE ACETONIDE CREAM
ManufacturerTRIAMCINOLONE ACETONIDE CREAM
Active SubstanceTRIAMCINOLONE ACETONIDE
Drug RouteTOPICAL
DistributionPhysicians and Medical Facilities in GA and ID
Quantity20 tubes
Recall ReasonCGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Drug ClassificationClass II
Drug Code Info20220921
Product NDC72189-330
Product NUIN0000175576 N0000175450
Pharma Class (EPC)Corticosteroid [EPC]
Recall Initiation Date20220912
Report Date20220921
Classification Date20220915
Address94 Worldwide Dr
Dawsonville, GA 30534-6828
United States
Recalling FirmDirect Rx
Initial Notification Letter
Unique Ingredient IdentifierF446C597KA
Drug Application NumberANDA086413
Structured Product Labeling (SPL ID)d92e9eaf-3a7a-76d7-e053-2995a90ae28d
Structured Product Labeling (SPL Set ID)d92e9eaf-3a79-76d7-e053-2995a90ae28d
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.