Reported Mar 8, 2023 · Terminated
Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 2; 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, 10 mg, Rx Only
- Packaged as
a) 90-count bottle NDC 16729-004-15UPC 3 16729 00415 2b) 1000-count bottle NDC 16729-004-17UPC 3 16729 00417 6
- Manufactured forAccord Healthcare, Inc., Durham, NC 27703
- Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
- Lot codes and dates
23 of 23 products
Products covered by this recall # Product as published 1 P2106923, Exp. Date 9/30/2023 2 R2101544, Exp. Date 10/31/2023 3 R2200732, Exp. Date 5/31/2025 4 P2101634, Exp. Date 2/28/2023 5 P2102370, Exp. Date 3/31/2023 6 P2102321, Exp. Date 3/31/2023 7 P2102411, Exp. Date 3/31/2023 8 P2102454, Exp. Date 3/31/2023 9 P2103991, Exp. Date 5/31/2023 10 R2100954, Exp. Date 6/30/2023 11 R2100947, Exp. Date 6/30/2023 12 R2100951, Exp. Date 6/30/2023 13 P2106242, Exp. Date 8/31/2023 14 P2106928, Exp. Date 9/30/2023 15 P2107424, Exp. Date 9/30/2023 16 R2101542, Exp. Date 10/31/2023 17 R2101543, Exp. Date 10/31/2023 18 R2200026, Exp. Date 11/30/2023 19 R2200414, Exp. Date 2/29/2024 20 R2200416, Exp. Date 2/28/2025 - Amount recalled
- 291,378 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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