Product Safety Recalls

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HALOBETASOL PROPIONATE Recall D-0689-2022

Description: Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15; b) 50 g tubes, NDC 52565-073-51, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

HALOBETASOL PROPIONATE Recall D-0689-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0689-2022
Event ID89798
BrandHALOBETASOL PROPIONATE
Generic NameHALOBETASOL PROPIONATE
ManufacturerHALOBETASOL PROPIONATE
Original Package?1
Active SubstanceHALOBETASOL PROPIONATE
Drug RouteTOPICAL
DistributionNationwide in the USA and Puerto Rico
Quantity161,331 tubes
Recall ReasoncGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Drug ClassificationClass II
Drug Code Info20220330
Product NDC52565-073
Recall Initiation Date20220315
Report Date20220330
Classification Date20220321
Address105 Lincoln Avenue
Buena, NJ 08310
United States
Recalling FirmTeligent Pharma, Inc.
Initial Notification Letter
Unique Ingredient Identifier91A0K1TY3Z
Drug Application NumberANDA209978
Structured Product Labeling (SPL ID)35da6f20-71cb-4679-8dca-bfd561b4c9fd
Structured Product Labeling (SPL Set ID)102dd731-6f73-458f-9d95-9cdf14a5df06
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