Product Safety Recalls

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HALOBETASOL PROPIONATE Recall D-0847-2022

Description: Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-998-67

HALOBETASOL PROPIONATE Recall D-0847-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0847-2022
Event ID89986
BrandHALOBETASOL PROPIONATE
Generic NameHALOBETASOL PROPIONATE
ManufacturerHALOBETASOL PROPIONATE
Original Package?1
Active SubstanceHALOBETASOL PROPIONATE
Drug RouteTOPICAL
DistributionNationwide in the United States including Guam and the Northern Mariana Islands.
Quantity13, 200 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 NDC63739-998
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 Identifier91A0K1TY3Z
Drug Application NumberANDA209978
Structured Product Labeling (SPL ID)de8d7dff-2dda-4bf2-afea-1d31b4038ec4
Structured Product Labeling (SPL Set ID)c82a72cb-4507-482f-969e-12f44721bfc7
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