Product Safety Recalls

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TRIAMCINOLONE ACETONIDE Recall D-1106-2022

Description: Triamcinolone Acetonide cream, USP, 0.1% ,15 grams tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0004-15

TRIAMCINOLONE ACETONIDE Recall D-1106-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1106-2022
Event ID89646
BrandTRIAMCINOLONE ACETONIDE
Generic NameTRIAMCINOLONE ACETONIDE
ManufacturerTRIAMCINOLONE ACETONIDE
Original Package?1
Active SubstanceTRIAMCINOLONE ACETONIDE
Drug RouteTOPICAL
DistributionUSA nationwide.
Quantity30 tubes
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0168-0002 0168-0003 0168-0004
Product NUIN0000175576 N0000175450
Drug UPC0301680003153 0301680002156 0301680004150
Pharma Class (EPC)Corticosteroid [EPC]
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient IdentifierF446C597KA
Drug Application NumberANDA085692
Structured Product Labeling (SPL ID)719f34d8-deb8-446f-a201-3f74fed4e831
Structured Product Labeling (SPL Set ID)92a1ded0-8e1a-4994-9c8a-89e84fc85c94
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