Reported Mar 8, 2023 · Terminated
Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5; 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 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5; b) 1,000 Tablets NDC 16729-045-17 UPC 3 16729 04517 9
- 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 R2100305, Exp. Date 2/28/2023 2 R2200227, Exp. Date 1/31/2024 3 R2200797, Exp. Date 6/30/2024 4 R2101423, R2101438, R2101447, R2101446, Exp. Date 10/31/2023 5 R2200040, R2200041, R2200052, R2200043, R2200044, R2200051, R2200060, R2200061, R2200062, R2200077, R2200078, Exp. Date 12/31/2023 6 R2200228, R2200480, Exp. Date 1/31/2024 7 R2200266, R2200267, R2200265, R2200268, Exp. Date 2/29/2024 8 R2200370, Exp. Date 3/31/2024 9 R2201038, Exp. Date 6/30/2024 - Amount recalled
- 241,585 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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