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
1R2100305, Exp. Date 2/28/2023
2R2200227, Exp. Date 1/31/2024
3R2200797, Exp. Date 6/30/2024
4R2101423, R2101438, R2101447, R2101446, Exp. Date 10/31/2023
5R2200040, R2200041, R2200052, R2200043, R2200044, R2200051, R2200060, R2200061, R2200062, R2200077, R2200078, Exp. Date 12/31/2023
6R2200228, R2200480, Exp. Date 1/31/2024
7R2200266, R2200267, R2200265, R2200268, Exp. Date 2/29/2024
8R2200370, Exp. Date 3/31/2024
9R2201038, 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 22, 2024 · Data as of Sep 19, 5:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.