Recalls / Class II
Class IID-0405-2023
Product
Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-285-15, UPC 3 16729 28515 5; b) 1,000-count bottle NDC 16729-285-17, UPC 3 16729 28517 9; 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) P2006824, Exp. Date 11/30/2023; P2102223, Exp. Date 3/31/2024; b) P2004949, Exp. Date 8/31/2023; P2004948, Exp. Date 8/31/2023; P2004950, Exp. Date 8/31/2023; P2004953, Exp. Date 8/31/2023; P2004954, Exp. Date 8/31/2023; P2004956, Exp. Date 8/31/2023; P2004955, Exp. Date 8/31/2023; P2004957, Exp. Date 8/31/2023; P2004958, Exp. Date 8/31/2023; P2004959, Exp. Date 8/31/2023; P2005252, Exp. Date 9/30/2023; P2006607, Exp. Date 11/30/2023; P2101368, Exp. Date 2/29/2024; P2101777, Exp. Date 2/29/2024; P2102224, Exp. Date 3/31/2024; P2104397, Exp. Date 6/30/2024; P2104395, Exp. Date 6/30/2024; P2104398, Exp. Date 6/30/2024; P2105120, Exp. Date 7/31/2024; P2204835, Exp. Date 7/31/2025; P2204834, Exp. Date 7/31/2025; P2204837, Exp. Date 7/31/2025; P2205832, Exp. Date 9/30/2025; P2205833, Exp. Date 9/30/2025;
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
- 56,862 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-0405-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.