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DIFLORASONE DIACETATE Recall D-0681-2022

Description: Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, LLC Baton Rouge, LA 70809, NDC 70512-031-60.

DIFLORASONE DIACETATE Recall D-0681-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0681-2022
Event ID89798
BrandDIFLORASONE DIACETATE OINT
Generic NameDIFLORASONE DIACETATE OINTMENT
ManufacturerDIFLORASONE DIACETATE OINTMENT
Original Package?1
Active SubstanceDIFLORASONE DIACETATE
Drug RouteTOPICAL
DistributionNationwide in the USA and Puerto Rico
Quantity24,304 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 NDC70512-031
Drug UPC0370512031602
Recall Initiation Date20220315
Report Date20220330
Classification Date20220321
Address105 Lincoln Avenue
Buena, NJ 08310
United States
Recalling FirmTeligent Pharma, Inc.
Initial Notification Letter
Unique Ingredient Identifier7W2J09SCWX
Drug Application NumberANDA210753
Structured Product Labeling (SPL ID)b8b8c0e8-fb69-048b-e053-2a95a90afbbb
Structured Product Labeling (SPL Set ID)81a55188-1f73-c212-e053-2991aa0a0719
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