D-0407-2023 Class II Terminated
FDA drug recall D-0407-2023 was initiated by Accord Healthcare, Inc. on February 7, 2023 and is designated Class II. Reason for recall: CGMP Deviations: recalling drug products following an FDA inspection. The recall status is terminated (terminated April 22, 2024). Affected quantity: 102,360 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 8, 2023
- Initiation Date
- February 7, 2023
- Termination Date
- April 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 102,360 bottles
Product Description
Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-287-10, UPC 3 16729 28710 4; b) 90-count bottle NDC 16729-287-15, UPC 3 16729 28715 9; c) 1,000-count bottle NDC 16729-287-17, UPC 3 16729 28717 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Distribution Pattern
United States including Puerto Rico and Canada
Code Information
Batches: a) P2100343, Exp. Date 12/31/2023; P2102371, Exp. Date 3/31/2024; b) P2101966, Exp. Date 2/28/2024; P2104545, Exp. Date 6/30/2024; P2204500, Exp. Date 7/31/2025; P2205415, Exp. Date 8/31/2025; c) P2101591, Exp. Date 2/28/2023; P2200062, Exp. Date 12/31/2024; P2204336, Exp. Date 7/31/2025; P2204337, Exp. Date 7/31/2025; P2205416, Exp. Date 8/31/2025;