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DESOXIMETASONE Recall D-0678-2022

Description: Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565-030-99; b) 60 grams tubes, NDC 52565-030-60; c) 15 grams tubes, NDC 52565-030-15, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.

DESOXIMETASONE Recall D-0678-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0678-2022
Event ID89798
Original Package?1
DistributionNationwide in the USA and Puerto Rico
Quantity13,989 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 NDC52565-030
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 Identifier4E07GXB7AU
Drug Application NumberANDA208101
Structured Product Labeling (SPL ID)02ded2db-0bf5-4b55-a8c7-19d06486c689
Structured Product Labeling (SPL Set ID)53d8d9ed-5749-4874-a345-be768c8a0e59
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