Reported Mar 8, 2023 · Terminated

Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; 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 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; b) 1,000 Tablets NDC 16729-046-17 UPC 3 16729 04617 6
  • Manufactured forAccord Healthcare, Inc., Durham
  • NC 27703 Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Lot codes and dates

10 of 10 products

Products covered by this recall
#Product as published
1R2100552, R2100553, Exp. Date 4/30/2023
2R2200253, Exp. Date 2/29/2024
3R2200627, Exp. Date 4/30/2024
4R2201113, Exp. Date 6/30/2024
5R2201184, Exp. Date 8/31/2024
6R2201366, Exp. Date 9/30/2024
7R2200280, Exp. Date 2/29/2024
8R2200385, R2200386, R2200491, R2200490, R2200494, R2200496, R2200495, Exp. Date 3/31/2024
9R2200510, R2200520, R2200521, R2200517, R2200511, R2200632, R2200631, R2200637, R2200635, R2200648, R2200638, R2200639, R2200647, Exp. Date 4/30/2024
10R2200727, Exp. Date 5/31/2024
Amount recalled
147,736 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, 6:38 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.