Reported Mar 8, 2023 · Terminated
Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-285-15, UPC 3 16729 28515 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?
- Rosuvastatin Tablets, USP, 10 mg*, Rx Only
- Packaged as
a) 90-count bottleNDC 16729-285-15UPC 3 16729 28515 5b) 1000-count bottle NDC 16729-285-17UPC 3 16729 28517 9
- Manufactured forAccord Healthcare, Inc., Durham, NC 27703
- Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
- Lot codes and dates
26 of 26 products
Products covered by this recall # Product as published 1 P2006824, Exp. Date 11/30/2023 2 P2102223, Exp. Date 3/31/2024 3 P2004949, Exp. Date 8/31/2023 4 P2004948, Exp. Date 8/31/2023 5 P2004950, Exp. Date 8/31/2023 6 P2004953, Exp. Date 8/31/2023 7 P2004954, Exp. Date 8/31/2023 8 P2004956, Exp. Date 8/31/2023 9 P2004955, Exp. Date 8/31/2023 10 P2004957, Exp. Date 8/31/2023 11 P2004958, Exp. Date 8/31/2023 12 P2004959, Exp. Date 8/31/2023 13 P2005252, Exp. Date 9/30/2023 14 P2006607, Exp. Date 11/30/2023 15 P2101368, Exp. Date 2/29/2024 16 P2101777, Exp. Date 2/29/2024 17 P2102224, Exp. Date 3/31/2024 18 P2104397, Exp. Date 6/30/2024 19 P2104395, Exp. Date 6/30/2024 20 P2104398, Exp. Date 6/30/2024 - Amount recalled
- 56,862 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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