Reported Mar 8, 2023 · Terminated
Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500…
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 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500 Tablets NDC 16729-047-16 UPC 3 16729 04716 6
- Manufactured forAccord Healthcare, Inc., Durham
- NC 27703 Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 R2100283, R2100288, R2100289, Exp. Date 2/28/2023 2 R2200235, Exp. Date 1/31/2024 3 R2201037, R2200952, Exp. Date 6/30/2024 4 R2100291, R2100281, R2100282, R2100292, R2100293, R2100294, R2100290, R2100306, R2100348, R2100349, R2100347, R2100350, R2100356, R2100355, Exp. Date 2/28/2023 5 R2100461, R2100463, R2100464, Exp. Date 3/31/2023 6 R2101214, R2101215, R2101216, Exp. Date 9/30/2023 7 R2101572, R2101573, R2101577, R2101578, R2101585, R2101579, R2101584, R2101587, R2101597, Exp. Date 11/30/2023 8 R2200801, Exp. Date 6/30/2024 - Amount recalled
- 72,376 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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