Reported Mar 8, 2023 · Terminated
Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 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?
- Rosuvastatin Tablets, USP 20 mg* Rx Only
- Packaged as
a) 90-count bottle NDC 16729-286-15UPC 3 16729 28615 2b) 1000-count bottles NDC 16729-286-17UPC 3 16729 28617 6
- Manufactured forAccord Healthcare, Inc., Durham, NC 27703
- Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
- Lot codes and dates
19 of 19 products
Products covered by this recall # Product as published 1 P2006560, Exp. Date 11/30/2023 2 P2101562, Exp. Date 2/28/2024 3 P2006561, Exp. Date 11/30/2023 4 P2006562, Exp. Date 11/30/2023 5 P2006587, Exp. Date 11/30/2023 6 P2100035, Exp. Date 11/30/2023 7 P2006600, Exp. Date 11/30/2023 8 P2006603, Exp. Date 11/30/2023 9 P2006604, Exp. Date 11/30/2023 10 P2006605, Exp. Date 11/30/2023 11 P2006606, Exp. Date 11/30/2023 12 P2100542, Exp. Date 12/31/2023 13 P2100543, Exp. Date 12/31/2023 14 P2100544, Exp. Date 12/31/2023 15 P2100545, Exp. Date 12/31/2023 16 P2101485, Exp. Date 2/28/2024 17 P2101484, Exp. Date 2/29/2024 18 P2205235, Exp. Date 8/31/2025 19 P2205236, Exp. Date 8/31/2025 - Amount recalled
- 43,302 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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