Reported Mar 8, 2023 · Terminated
Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; 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, 5 mg Rx Only
- Packaged as
a) 30-count bottle NDC 16729-370-10UPC 3 16729 37010 3b) 500-count bottle NDC 16729-370-16UPC 3 16729 37016 5
- Manufactured forAccord Healthcare, Inc., Durham, NC 27703
- Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
- Lot codes and dates
64 of 64 products
Products covered by this recall # Product as published 1 P2002450, Exp. Date 4/30/2023, P2003222, Exp. Date 5/31/2023 2 P2003223, Exp. Date 5/31/2023 3 P2003224, Exp. Date 5/31/2023 4 P2004636, Exp. Date 8/31/2023 5 P2005035, Exp. Date 8/31/2023 6 P2005038, Exp. Date 8/31/2023 7 P2005040, Exp. Date 8/31/2023 8 P2005039, Exp. Date 8/31/2023 9 P2005041, Exp. Date 8/31/2023 10 P2005606, Exp. Date 9/30/2023 11 P2100340, Exp. Date 9/30/2023 12 P2100009, Exp. Date 12/31/2023 13 P2100010, Exp. Date 12/31/2023 14 P2100044, Exp. Date 12/31/2023 15 P2100045, Exp. Date 12/31/2023 16 P2100046, Exp. Date 12/31/2023 17 P2101129, Exp. Date 1/31/2024 18 P2101880, Exp. Date 1/31/2024 19 P2101130, Exp. Date 1/31/2024 20 P2101131, Exp. Date 1/31/2024 - Amount recalled
- 1,113,264 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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