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ECONAZOLE NITRATE Recall D-0682-2022

Description: Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) 85 grams tubes, NDC 52565-022-85; c) 30 grams tubes, NDC 52565-022-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.

ECONAZOLE NITRATE Recall D-0682-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0682-2022
Event ID89798
BrandECONAZOLE NITRATE
Generic NameECONAZOLE NITRATE
ManufacturerECONAZOLE NITRATE
Original Package?1
Active SubstanceECONAZOLE NITRATE
Drug RouteTOPICAL
DistributionNationwide in the USA and Puerto Rico
Quantity151,975 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 NDC52565-022
Recall Initiation Date20220315
Report Date20220330
Classification Date20220321
Address105 Lincoln Avenue
Buena, NJ 08310
United States
Recalling FirmTeligent Pharma, Inc.
Initial Notification Letter
Unique Ingredient IdentifierH438WYN10E
Drug Application NumberANDA076574
Structured Product Labeling (SPL ID)4fbee603-de52-4aec-b5eb-8cf29a8a01db
Structured Product Labeling (SPL Set ID)51fd5746-8313-4f68-b929-8481ad8ca241
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