Product Safety Recalls

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DESOXIMETASONE Recall D-0676-2022

Description: Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-037-10.

DESOXIMETASONE Recall D-0676-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0676-2022
Event ID89798
BrandDESOXIMETASONE OINT 0.05%
Generic NameDESOXIMETASONE OINT 0.05%
ManufacturerDESOXIMETASONE OINT 0.05%
Original Package?1
Active SubstanceDESOXIMETASONE
Drug RouteTOPICAL
DistributionNationwide in the USA and Puerto Rico
Quantity6850 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 NDC70512-037
Product NUIN0000175576 N0000175450
Drug UPC0370512037109 0370512037604
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 NumberANDA209973
Structured Product Labeling (SPL ID)a3e48b6e-4bd6-330d-e053-2995a90a75fe
Structured Product Labeling (SPL Set ID)a3e48b6e-4bd5-330d-e053-2995a90a75fe
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