Reported Mar 8, 2023 · Terminated
Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; 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 40 mg Rx Only
- Packaged as
a) 90-count tablets NDC 16729-006-15UPC 3 16729 00615 6b) 1000-count tablets NDC 16729-006-17UPC 3 16729 00617 0
- Manufactured forAccord Healthcare, Inc., Durham, NC 27703
- Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
- Lot codes and dates
- Batches
187 of 187 codes
a) P2103713P2103692Exp. Date 5/31/2023P2104950P2104984P2104969P2104996P2105274P2105314P2105316Exp. Date 7/31/2023R2101074R2101077R2101078R2101079R2101083R2101084R2101117Exp. Date 8/31/2023R2101330R2101331R2101335R2101336R2101334R2101337R2101339Exp. Date 9/30/2023R2101494R2101495R2101496R2101497Exp. Date 10/31/2023R2200527R2200531Exp. Date 3/31/2024R2200606R2200625Exp. Date 4/30/2024b) P2101911P2101913R2100344R2100351R2100354R2100346R2100357R2100358R2100359R2100361R2100362R2100385R2100386R2100388R2100394R2100397R2100345Exp. Date 2/28/2023P2101930P2101983R2100435R2100457
- Batches
- Amount recalled
- 1,190,484 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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