D-0383-2023 Class II Terminated
FDA drug recall D-0383-2023 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: 37,790 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
- 37,790 bottles
Product Description
Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-490-12 UPC 3 16729 49012 2
Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Distribution Pattern
United States including Puerto Rico and Canada
Code Information
Batches: P2101480, Exp. Date 2/28/2023; P2102579, P2102596, Exp. Date 4/30/2023; P2104711, P2104707, Exp. Date 6/30/2023; P2200771, P2200829, P2200795, Exp. Date 12/31/2023; P2202608, Exp. Date 4/30/2025; P2203492, P2203463, Exp. Date 5/31/2025; P2205373, P2205412, Exp. Date 8/31/2025;