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FLUTICASONE PROPIONATE Recall D-1172-2022

Description: Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC 50383-700-16

FLUTICASONE PROPIONATE Recall D-1172-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1172-2022
Event ID90405
BrandFLUTICASONE PROPIONATE
Generic NameFLUTICASONE PROPIONATE
ManufacturerFLUTICASONE PROPIONATE
Original Package?1
Active SubstanceFLUTICASONE PROPIONATE
Drug RouteNASAL
DistributionNationwide USA
Quantity44,400 bottles
Recall ReasonDefective container: defect prevents product from dispensing as intended.
Drug ClassificationClass II
Drug Code Info20220706
Product NDC50383-700
Recall Initiation Date20220613
Report Date20220706
Classification Date20220630
Address1925 W Field Ct Ste 300
Lake Forest, IL 60045-4862
United States
Recalling FirmAkorn, Inc.
Initial Notification Letter
Unique Ingredient IdentifierO2GMZ0LF5W
Drug Application NumberANDA077570
Structured Product Labeling (SPL ID)4f61c3c9-e855-4c87-a257-ed2860c866e3
Structured Product Labeling (SPL Set ID)b7ea1841-2fb1-48c8-86f9-639893fd1a84
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