Reported Mar 8, 2023 · Terminated
Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 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?
- Simvastatin Tablets USP 80 mg Rx Only
- Packaged as
a) 90-count bottle NDC 16729-007-15UPC 3 16729 00715 3b) 1000-count bottle NDC 16729-007-17UPC 3 16729 00717 7
- Manufactured forAccord Healthcare, Inc., Durham, NC 27703
- Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
- Lot codes and dates
- Batches
a) R2100387R2100393Exp. Date 2/28/2023P2102556P2102558P2102636Exp. Date 4/30/2023P2103981P2103877P2103958Exp. Date 5/31/2023R2101393R2101395R2101394Exp. Date 10/31/2023P2202681P2202653Exp. Date 4/30/2025b)R2000555R2000587R2000599R2000604Exp. Date 9/30/2023P2100023P2006857Exp. Date 11/30/2023P2101094P2101096P2101110P2101111P2101113P2101145P2101198P2101223P2101199Exp. Date 1/31/2024P2101877P2101885P2101886P2101929R2100402R2100406R2100403Exp. Date 2/28/2024P2101786P2101787P2101789P2101790Exp. Date 2/29/2024R2100440R2100439Exp. Date 3/31/2024
- Batches
- Amount recalled
- 205,631 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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