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 1 R2100552, R2100553, Exp. Date 4/30/2023 2 R2200253, Exp. Date 2/29/2024 3 R2200627, Exp. Date 4/30/2024 4 R2201113, Exp. Date 6/30/2024 5 R2201184, Exp. Date 8/31/2024 6 R2201366, Exp. Date 9/30/2024 7 R2200280, Exp. Date 2/29/2024 8 R2200385, R2200386, R2200491, R2200490, R2200494, R2200496, R2200495, Exp. Date 3/31/2024 9 R2200510, R2200520, R2200521, R2200517, R2200511, R2200632, R2200631, R2200637, R2200635, R2200648, R2200638, R2200639, R2200647, Exp. Date 4/30/2024 10 R2200727, 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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