Product Safety Recalls

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BETAMETHASONE DIPROPIONATE Recall D-0669-2022

Description: Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams) bottles, NDC 52565-023-59, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310

BETAMETHASONE DIPROPIONATE Recall D-0669-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0669-2022
Event ID89798
BrandBETAMETHASONE DIPROPIONATE
Generic NameBETAMETHASONE DIPROPIONATE
ManufacturerBETAMETHASONE DIPROPIONATE
Original Package?1
Active SubstanceBETAMETHASONE DIPROPIONATE
Drug RouteTOPICAL
DistributionNationwide in the USA and Puerto Rico
Quantity43,218 bottles
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 NDC52565-023
Drug UPC0352565023292
Recall Initiation Date20220315
Report Date20220330
Classification Date20220321
Address105 Lincoln Avenue
Buena, NJ 08310
United States
Recalling FirmTeligent Pharma, Inc.
Initial Notification Letter
Unique Ingredient Identifier826Y60901U
Drug Application NumberANDA206389
Structured Product Labeling (SPL ID)3e7bbd47-5cf6-4aac-9653-271bf6e4d584
Structured Product Labeling (SPL Set ID)3b4b9e5a-769d-7034-c381-6796837a2e24
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