Reported Mar 8, 2023 · Terminated
Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; 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, 20 mg, Rx Only
- Packaged as
a) 30-count bottle NDC 16729-372-10UPC 3 16729 37210 7b) 500-count bottle NDC 16729-372-16UPC 3 16729 37216 9
- 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 P2002461, Exp. Date 4/30/2023 2 P2002457, Exp. Date 4/30/2023 3 P2002460, Exp. Date 4/30/2023 4 P2002464, Exp. Date 4/30/2023 5 P2002463, Exp. Date 4/30/2023 6 P2002462, Exp. Date 4/30/2023 7 P2002465, Exp. Date 4/30/2023 8 P2003153, Exp. Date 5/31/2023 9 P2003155, Exp. Date 5/31/2023 10 P2003156, Exp. Date 5/31/2023 11 P2003154, Exp. Date 5/31/2023 12 P2003152, Exp. Date 5/31/2023 13 P2003157, Exp. Date 5/31/2023 14 P2003158, Exp. Date 5/31/2023 15 P2003159, Exp. Date 5/31/2023 16 P2003162, Exp. Date 5/31/2023 17 P2003160, Exp. Date 5/31/2023 18 P2003778, Exp. Date 6/30/2023 19 P2003779, Exp. Date 6/30/2023 20 P2004315, Exp. Date 6/30/2023 - Amount recalled
- 613,553 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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