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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0553-2023 |
| Event ID | 91944 |
| Brand | TADALAFIL |
| Generic Name | TADALAFIL |
| Manufacturer | TADALAFIL |
| Active Substance | TADALAFIL |
| Drug Route | ORAL |
| Distribution | Nationwide with the United States |
| Quantity | a)164 bottles; b) 198 bottles |
| Recall Reason | CGMP Deviations |
| Drug Classification | Class II |
| Drug Code Info | 20230503 |
| Product NDC | 51655-473 |
| Product NUI | N0000175599 N0000020026 |
| Pharma Class (EPC) | Phosphodiesterase 5 Inhibitor [EPC] |
| Recall Initiation Date | 20230316 |
| Report Date | 20230503 |
| Classification Date | 20230426 |
| Address | 4838 Fletcher Ave Ste 1000 Indianapolis, IN 46203-1642 United States |
| Recalling Firm | Northwind Pharmaceuticals LLC |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Unique Ingredient Identifier | 742SXX0ICT |
| Drug Application Number | ANDA209167 |
| 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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