Recalls / Class II
Class IID-0406-2023
Product
Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 2; b) 1,000-count bottles NDC 16729-286-17, UPC 3 16729 28617 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
- Brand name
- Rosuvastatin
- Generic name
- Rosuvastatin
- Active ingredient
- Rosuvastatin Calcium
- Route
- Oral
- NDCs
- 16729-284, 16729-285, 16729-286, 16729-287
- FDA application
- ANDA206434
- Affected lot / code info
- Batches: a) P2006560, Exp. Date 11/30/2023; P2101562, Exp. Date 2/28/2024; b) P2006561, Exp. Date 11/30/2023; P2006562, Exp. Date 11/30/2023; P2006587, Exp. Date 11/30/2023; P2100035, Exp. Date 11/30/2023; P2006600, Exp. Date 11/30/2023; P2006603, Exp. Date 11/30/2023; P2006604, Exp. Date 11/30/2023; P2006605, Exp. Date 11/30/2023; P2006606, Exp. Date 11/30/2023; P2100542, Exp. Date 12/31/2023; P2100543, Exp. Date 12/31/2023; P2100544, Exp. Date 12/31/2023; P2100545, Exp. Date 12/31/2023; P2101485, Exp. Date 2/28/2024; P2101484, Exp. Date 2/29/2024; P2205235, Exp. Date 8/31/2025; P2205236, Exp. Date 8/31/2025;
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
Recalling firm
- Firm
- Accord Healthcare, Inc.
- Manufacturer
- Accord Healthcare Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1009 Slater Rd Ste 210B, N/A, Durham, North Carolina 27703-8446
Distribution
- Quantity
- 43,302 bottles
- Distribution pattern
- United States including Puerto Rico and Canada
Timeline
- Recall initiated
- 2023-02-07
- FDA classified
- 2023-03-02
- Posted by FDA
- 2023-03-08
- Terminated
- 2024-04-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0406-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.