Reported Mar 8, 2023 · Terminated
Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; 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, 5 mg*, Rx Only
- Packaged as
a) 90-count bottleNDC 16729-284-15UPC 3 16729 28415 8b) 1000-count bottleNDC 16729-284-17UPC 3 16729 28417 2
- Manufactured forAccord Healthcare, Inc., Durham, NC 27703
- Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
- Lot codes and dates
21 of 21 products
Products covered by this recall # Product as published 1 P2101063, Exp. Date 1/31/2024 2 P2101707, Exp. Date 2/29/2024 3 P2203913 Exp. Date 6/30/2025 4 P2101064, Exp. Date 1/31/2024 5 P2101539, Exp. Date 1/31/2024 6 P2101709, Exp. Date 2/29/2024 7 P2102138, Exp. Date 2/29/2024 8 P2103186, Exp. Date 5/31/2024 9 P2104430, Exp. Date 6/30/2024 10 P2104703, Exp. Date 7/31/2024 11 P2104704, Exp. Date 7/31/2024 12 P2104705, Exp. Date 7/31/2024 13 P2104702, Exp. Date 7/31/2024 14 P2107176, Exp. Date 10/31/2024 15 P2107177, Exp. Date 10/31/2024 16 P2107178, Exp. Date 10/31/2024 17 P2107181, Exp. Date 10/31/2024 18 P2203915, Exp. Date 6/30/2025 19 P2203914, Exp. Date 6/30/2025 20 P2204998, Exp. Date 8/31/2025 - Amount recalled
- 63,247 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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