Product Safety Recalls

Product Recall Tracker

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

Mandated?Voluntary: Firm initiated
Recall NumberD-0414-2023
Event ID91657
Original Package?1
Active SubstanceTADALAFIL
Drug RouteORAL
DistributionUnited States including Puerto Rico and Canada
Quantity36,773 bottles
Recall ReasonCGMP Deviations: recalling drug products following an FDA inspection.
Drug ClassificationClass II
Drug Code Info20230308
Product NDC16729-369 16729-370 16729-371
Product NUIN0000175599 N0000020026
Drug UPC316729369107 316729369169
Pharma Class (EPC)Phosphodiesterase 5 Inhibitor [EPC]
Recall Initiation Date20230207
Report Date20230308
Classification Date20230302
Address1009 Slater Rd Ste 210B
Durham, NC 27703-8446
United States
Recalling FirmAccord Healthcare, Inc.
Initial Notification Letter
Unique Ingredient Identifier742SXX0ICT
Drug Application NumberANDA209167
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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