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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