Product Safety Recalls

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TADALAFIL Recall D-0553-2023

Description: Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.

TADALAFIL Recall D-0553-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0553-2023
Event ID91944
Active SubstanceTADALAFIL
Drug RouteORAL
DistributionNationwide with the United States
Quantitya)164 bottles; b) 198 bottles
Recall ReasonCGMP Deviations
Drug ClassificationClass II
Drug Code Info20230503
Product NDC51655-473
Product NUIN0000175599 N0000020026
Pharma Class (EPC)Phosphodiesterase 5 Inhibitor [EPC]
Recall Initiation Date20230316
Report Date20230503
Classification Date20230426
Address4838 Fletcher Ave Ste 1000
Indianapolis, IN 46203-1642
United States
Recalling FirmNorthwind Pharmaceuticals LLC
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Unique Ingredient Identifier742SXX0ICT
Drug Application NumberANDA209167
Structured Product Labeling (SPL ID)f309302f-d6e7-997e-e053-2995a90a14e5
Structured Product Labeling (SPL Set ID)f3092f5a-b976-91ab-e053-2995a90a9b50
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