Product Safety Recalls

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ESTRADIOL Recall D-0180-2024

Description: ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-0899-02

ESTRADIOL Recall D-0180-2024 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0180-2024
Event ID89450
Original Package?1
Active SubstanceESTRADIOL
Drug RouteORAL
DistributionNationwide USA
Quantity1 unit
Recall ReasonCGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Drug ClassificationClass II
Drug Code Info20240103
Product NDC0555-0886 0555-0899 0555-0887
Product NUIM0447348 N0000175825 N0000000100
Pharma Class (EPC)Estrogen [EPC]
Pharma Class (CS)Estradiol Congeners [CS]
Recall Initiation Date20220126
Report Date20240103
Classification Date20231226
Address7200 Cardinal Pl W
Dublin, OH 43017-1094
United States
Initial Notification Letter
Unique Ingredient Identifier4TI98Z838E
Drug Application NumberANDA040197
Structured Product Labeling (SPL ID)80d8c060-3bbd-4010-9402-b191ec10717e
Structured Product Labeling (SPL Set ID)c4936878-1643-4e7f-9b0d-e4957935aef2
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