FDAFDA · Food and drugs·Recall number D-0416-2023
Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b) 500-count bottle NDC 16729-371-16, UPC 3 16729 37116 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
Published March 8, 2023 · Recall initiated: February 7, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: recalling drug products following an FDA inspection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TADALAFIL
- Manufacturer
- Accord Healthcare, Inc.
- Distributor
- United States including Puerto Rico and Canada
- UPC
- 0316729372107
- Lot
- Batches: a) P2002525, Exp. Date 4/30/2023; P2004442, Exp. Date 7/31/2023; P2005014, Exp. Date 8/31/2023; P2005015, Exp. Date 8/31/2023; P2005016, Exp. Date 8/31/2023; P2005825, Exp. Date 10/31/2023; P2005824, Exp. Date 10/31/2023; P2005826, Exp. Date 10/31/2023; P2100368, Exp. Date 12/31/2023; P2100444, Exp. Date 12/31/2023; P2101262, Exp. Date 2/29/2024; P2101263, Exp. Date 2/29/2024; P2200813, Exp. Date 1/31/2025; P2200814, Exp. Date 1/31/2025; b) P2002526, Exp. Date 4/30/2023; P2003781, Exp. Date 6/30/2023; P2003782, Exp. Date 6/30/2023; P2003783, Exp. Date 6/30/2023; P2004440, Exp. Date 7/31/2023; P2004441, Exp. Date 7/31/2023; P2005820, Exp. Date 10/31/2023; P2005821, Exp. Date 10/31/2023; P2005823, Exp. Date 10/31/2023; P2100077, Exp. Date 12/31/2023; P2100076, Exp. Date 12/31/2023; P2100078, Exp. Date 12/31/2023; P2100079, Exp. Date 12/31/2023; P2100080, Exp. Date 12/31/2023; P2100366, Exp. Date 12/31/2023; P2100442, Exp. Date 12/31/2023; P2100443, Exp. Date 12/31/2023; P2101265, Exp. Date 2/29/2024; P2101264, Exp. Date 2/29/2024; P2101718, Exp. Date 2/29/2024; P2108091, Exp. Date 11/30/2024; P2108092, Exp. Date 11/30/2024; P2108093, Exp. Date 11/30/2024; P2203589, Exp. Date 6/30/2025; P2203588, Exp. Date 6/30/2025; P2205379, Exp. Date 8/31/2025;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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