Product Safety Recalls

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DESONIDE Recall D-0675-2022

Description: Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 g tubes, NDC 52565-038-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

DESONIDE Recall D-0675-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0675-2022
Event ID89798
Generic NameDESONIDE
Original Package?1
Active SubstanceDESONIDE
DistributionNationwide in the USA and Puerto Rico
Quantity36,426 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 NDC52565-038
Product NUIN0000175576 N0000175450
Pharma Class (EPC)Corticosteroid [EPC]
Recall Initiation Date20220315
Report Date20220330
Classification Date20220321
Address105 Lincoln Avenue
Buena, NJ 08310
United States
Recalling FirmTeligent Pharma, Inc.
Initial Notification Letter
Unique Ingredient IdentifierJ280872D1O
Drug Application NumberANDA212002
Structured Product Labeling (SPL ID)0b2d209c-8b07-4ff6-9180-49f0e83b4443
Structured Product Labeling (SPL Set ID)6b2b161f-8ddf-4b16-973f-b32059f9c4d1
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