Reported Mar 8, 2023 · Terminated
Simvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-156-15, UPC 3 16729 15615 8; 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 5 mg Rx Only
- Packaged as
a) 90-count bottle NDC 16729-156-15UPC 3 16729 15615 8b) 1000-count bottle NDC 16729-156-17UPC 3 16729 15617 2
- Manufactured forAccord Healthcare, Inc., Durham, NC 27703
- Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
- Lot codes and dates
18 of 18 products
Products covered by this recall # Product as published 1 R2100818, Exp. Date 6/30/2023 2 R2100964, Exp. Date 6/30/2023 3 R2100824, Exp. Date 6/30/2023 4 R2100820, Exp. Date 6/30/2023 5 R2100822, Exp. Date 6/30/2023 6 R2101201, Exp. Date 9/30/2023 7 R2101198, Exp. Date 9/30/2023 8 R2101199, Exp. Date 9/30/2023 9 R2101200, Exp. Date 9/30/2023 10 R2101355, Exp. Date 10/31/2023 11 R2200035, Exp. Date 10/31/2023 12 R2200515, Exp. Date 4/30/2025 13 R2200514, Exp. Date 4/30/2025 14 R2200516, Exp. Date 4/30/2025 15 R2200310, Exp Date 9/30/2023 16 R2101354, Exp. Date 10/31/2023 17 R2200513, Exp. Date 4/30/2025 18 R2200768, Exp. Date 5/31/2025 - Amount recalled
- 256,648 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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