Product Safety Recalls

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BETAMETHASONE DIPROPIONATE Recall D-0850-2022

Description: Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-65

BETAMETHASONE DIPROPIONATE Recall D-0850-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0850-2022
Event ID89986
BrandBETAMETHASONE DIPROPIONATE
Generic NameBETAMETHASONE DIPROPIONATE
ManufacturerBETAMETHASONE DIPROPIONATE
Original Package?1
Active SubstanceBETAMETHASONE DIPROPIONATE
Drug RouteTOPICAL
DistributionNationwide in the United States including Guam and the Northern Mariana Islands.
Quantity55,440 tubes
Recall ReasonCGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Drug ClassificationClass II
Drug Code Info20220511
Product NDC63739-996
Recall Initiation Date20220421
Report Date20220511
Classification Date20220505
Address4853 Crumpler Rd
Memphis, TN 38141-8301
United States
Recalling FirmMcKesson Corporation dba McKesson Drug Company
Initial Notification Letter
Unique Ingredient Identifier826Y60901U
Drug Application NumberANDA206118
Structured Product Labeling (SPL ID)2e6365d8-cbee-42dd-b919-373edf1ce243
Structured Product Labeling (SPL Set ID)51530f90-6587-494d-8059-610820fa5d0b
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