Reported Mar 8, 2023 · Terminated
Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15, UPC 3 16729 00515 9; 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 20 mg Rx Only
- Packaged as
a) 90-count bottle NDC 16729-005-15UPC 3 16729 00515 9b) 1000-count bottle NDC 16729-005-17UPC 3 16729 00517 3
- Manufactured forAccord Healthcare, Inc., Durham, NC 27703
- Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
- Lot codes and dates
- Batches
166 of 166 codes
a) P2102261P2102284P2102319Exp. Date 3/31/2023P2103536Exp. Date 5/31/2023P2104344P2104342P2104355P2104356P2104296P2104380Exp. Date 6/30/2023R2200238R2200239Exp. Date 1/31/2024R2200383Exp. Date 2/28/2025b) R2000554R2000553Exp. Date 9/30/2023P2100562P2100563Exp. Date 12/31/2023P2100692P2100693P2100722P2100761P2100762P2101225P2101200P2101148P2101149P2101276P2101345Exp. Date 1/31/2024P2101622P2101664P2101638P2101785P2101904Exp. Date 2/29/2024P2101951P2101984P2102367P2102369P2102368P2102311P2102316P2102406P2102455Exp. Date 3/31/2024P2102553P2102554P2102635P2103233P2103253Exp. Date 4/30/2024P2103360P2103322
- Batches
- Amount recalled
- 1,394,208 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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