TADALAFIL Recall D-0414-2023
Description: Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; b) 500-count bottle NDC 16729-369-16, UPC 3 16729 36916 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
TADALAFIL Recall D-0414-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0414-2023 |
| Event ID | 91657 |
| Brand | TADALAFIL |
| Generic Name | TADALAFIL |
| Manufacturer | TADALAFIL |
| Original Package? | 1 |
| Active Substance | TADALAFIL |
| Drug Route | ORAL |
| Distribution | United States including Puerto Rico and Canada |
| Quantity | 36,773 bottles |
| Recall Reason | CGMP Deviations: recalling drug products following an FDA inspection. |
| Drug Classification | Class II |
| Drug Code Info | 20230308 |
| Product NDC | 16729-369 16729-370 16729-371 |
| Product NUI | N0000175599 N0000020026 |
| Drug UPC | 316729369107 316729369169 |
| Pharma Class (EPC) | Phosphodiesterase 5 Inhibitor [EPC] |
| Recall Initiation Date | 20230207 |
| Report Date | 20230308 |
| Classification Date | 20230302 |
| Address | 1009 Slater Rd Ste 210B Durham, NC 27703-8446 United States |
| Recalling Firm | Accord Healthcare, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 742SXX0ICT |
| Drug Application Number | ANDA209167 |
| Structured Product Labeling (SPL ID) | c4e0ddda-77b1-54e6-e053-2a95a90a87ba |
| Structured Product Labeling (SPL Set ID) | eedf3ad9-7d40-496d-b1a9-6200010c18e1 |
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