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BETAMETHASONE DIPROPIONATE Recall D-0727-2022

Description: Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4048-1

BETAMETHASONE DIPROPIONATE Recall D-0727-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0727-2022
Event ID89678
BrandCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
Generic NameCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ManufacturerCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
Original Package?1
Active SubstanceBETAMETHASONE DIPROPIONATE CLOTRIMAZOLE
Drug RouteTOPICAL
DistributionProduct was distributed to one retail consignee in NY.
Quantity768 tubes
Recall ReasonFailed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Drug ClassificationClass III
Drug Code Info20220406
Product NDC51672-4048
Product NUIN0000175487 M0002083
Pharma Class (EPC)Azole Antifungal [EPC]
Pharma Class (CS)Azoles [CS]
Recall Initiation Date20220225
Report Date20220406
Classification Date20220329
Address3 Skyline Dr
Hawthorne, NY 10532-2174
United States
Recalling FirmTaro Pharmaceuticals U.S.A., Inc.
Initial Notification Letter
Unique Ingredient Identifier826Y60901U G07GZ97H65
Drug Application NumberANDA075673
Structured Product Labeling (SPL ID)360f672f-0ae0-47b7-b71b-371a471a2060
Structured Product Labeling (SPL Set ID)1c18e5fc-bf82-47bc-bfd9-8d3e503569ba
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