Reported Mar 8, 2023 · Terminated
Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 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?
- Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8; b) 1,000 Tablets NDC 16729-044-17 UPC 3 16729 04417 2
- Manufactured forAccord Healthcare, Inc., Durham, NC 27703
- Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
- Lot codes and dates
9 of 9 products
Products covered by this recall # Product as published 1 R2100455, Exp. Date 3/31/2023 2 R2200274, Exp. Date 1/31/2024 3 R2200700, Exp. Date 5/31/2024 4 R2101342, R2101343, R2101476, Exp. Date 9/30/2023 5 R2101364, R2101365, R2101366, R2101367, Exp. Date 10/31/2023 6 R2101612, R2101613, R2101614, Exp. Date 11/30/2023 7 R2200222, R2200221, R2200223, Exp. Date 1/31/2024 8 R2200795, R2200713, R2200701, R2200711, R2200712, R2200756, R2200757, R2200754, R2200755, Exp. Date 5/31/2024 9 R2200945, R2200943, Exp. Date 6/30/2024 - Amount recalled
- 256,106 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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