Reported Mar 8, 2023 · Terminated
Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b)…
Accord Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accord Healthcare, Inc. · 1009 Slater Rd Ste 210B · Durham, NC · 27703-8446
Is this the product you have?
- Tadalafil Tablets, USP 10 mg Rx Only
- Packaged as
a) 30-count bottle NDC 16729-371-10UPC 3 16729 37110 0b) 500-count bottle NDC 16729-371-16UPC 3 16729 37116 2
- Manufactured forAccord Healthcare, Inc., Durham, NC 27703
- Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
- Lot codes and dates
40 of 40 products
Products covered by this recall # Product as published 1 P2002525, Exp. Date 4/30/2023 2 P2004442, Exp. Date 7/31/2023 3 P2005014, Exp. Date 8/31/2023 4 P2005015, Exp. Date 8/31/2023 5 P2005016, Exp. Date 8/31/2023 6 P2005825, Exp. Date 10/31/2023 7 P2005824, Exp. Date 10/31/2023 8 P2005826, Exp. Date 10/31/2023 9 P2100368, Exp. Date 12/31/2023 10 P2100444, Exp. Date 12/31/2023 11 P2101262, Exp. Date 2/29/2024 12 P2101263, Exp. Date 2/29/2024 13 P2200813, Exp. Date 1/31/2025 14 P2200814, Exp. Date 1/31/2025 15 P2002526, Exp. Date 4/30/2023 16 P2003781, Exp. Date 6/30/2023 17 P2003782, Exp. Date 6/30/2023 18 P2003783, Exp. Date 6/30/2023 19 P2004440, Exp. Date 7/31/2023 20 P2004441, Exp. Date 7/31/2023 - Amount recalled
- 176,323 bottles
This recall covers 67 products
The agency filed one notice per product. You are reading one of them; the other 66 are below.
54 more are in the archive.
Where it was sold
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
This product could cause temporary or reversible health problems — stop using it.
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