Reported Mar 8, 2023 · Terminated
Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as
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?
Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 30-count bottle NDC 16729-287-10, UPC 3 16729 28710 4 |
| 2 | 90-count bottle NDC 16729-287-15, UPC 3 16729 28715 9 |
| 3 | 1,000-count bottle NDC 16729-287-17, UPC 3 16729 28717 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA |
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 P2100343, Exp. Date 12/31/2023; P2102371, Exp. Date 3/31/2024 2 P2101966, Exp. Date 2/28/2024; P2104545, Exp. Date 6/30/2024; P2204500, Exp. Date 7/31/2025; P2205415, Exp. Date 8/31/2025 3 P2101591, Exp. Date 2/28/2023; P2200062, Exp. Date 12/31/2024; P2204336, Exp. Date 7/31/2025; P2204337, Exp. Date 7/31/2025; P2205416, Exp. Date 8/31/2025 - Amount recalled
- 102,360 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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