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CLOBETASOL PROPIONATE Recall D-0674-2022

Description: Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15; b) 30 grams tube, NDC 52565-082-30; c) 60 grams tube, NDC 52565-082-60, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.

CLOBETASOL PROPIONATE Recall D-0674-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0674-2022
Event ID89798
BrandCLOBETASOL PROPIONATE
Generic NameCLOBETASOL PROPIONATE
ManufacturerCLOBETASOL PROPIONATE
Original Package?1
Active SubstanceCLOBETASOL PROPIONATE
Drug RouteTOPICAL
DistributionNationwide in the USA and Puerto Rico
Quantity81,883 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 NDC52565-082
Recall Initiation Date20220315
Report Date20220330
Classification Date20220321
Address105 Lincoln Avenue
Buena, NJ 08310
United States
Recalling FirmTeligent Pharma, Inc.
Initial Notification Letter
Unique Ingredient Identifier779619577M
Drug Application NumberANDA208881
Structured Product Labeling (SPL ID)9fe1fe25-3ee4-4426-ba64-a5d2c2545b80
Structured Product Labeling (SPL Set ID)16035e8f-8570-f91e-f766-a68c34811cbc
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