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BETAMETHASONE DIPROPIONATE Recall D-1028-2022

Description: Betamethasone Dipropionate Cream USP, 0.05%, 45 grams tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0055-46

BETAMETHASONE DIPROPIONATE Recall D-1028-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1028-2022
Event ID89646
BrandBETAMETHASONE DIPROPIONATE
Generic NameBETAMETHASONE DIPROPIONATE
ManufacturerBETAMETHASONE DIPROPIONATE
Original Package?1
Active SubstanceBETAMETHASONE DIPROPIONATE
Drug RouteTOPICAL
DistributionUSA nationwide.
Quantity1 tube
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0168-0055 0168-0056 0168-0057
Drug UPC0301680056159 0301680055466
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 Identifier826Y60901U
Drug Application NumberNDA019137
Structured Product Labeling (SPL ID)f50b2abb-1a2d-4509-b1fe-617d9a4556a4
Structured Product Labeling (SPL Set ID)97dde5f5-a865-4af2-b562-8da72c8475f3
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