Status
Terminated
Drug Enforcement D-0384-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Classification
Class II
Report Date
March 8, 2023
Termination Date
April 22, 2024
Product Information
- Product description
- Dofetilide Capsules 250 mcg (0.25 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 16729-491-12 UPC 3 16729 49112 9
- Product quantity
- 113,571 bottles
- Reason for recall
- CGMP Deviations: recalling drug products following an FDA inspection.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- United States including Puerto Rico and Canada
Location & Firm
- Recalling firm
- ACCORD HEALTHCARE, INC.
- Address
-
1009 Slater Rd Ste 210B, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0384-2023
- Event ID
- 91657
- Recall initiation date
- February 7, 2023
- Center classification date
- March 2, 2023
- Code info
- Batches: P2101481 Exp. Date 2/28/2023; P2101985, P2101958, P2102019, Exp. Date 3/31/2023; P2102580, P2102597, Exp. Date 4/30/2023; P2104708, P2104712, Exp. Date 6/30/2023; P2107154, P2107187, Exp. Date 10/31/2023; P2107874, Exp. Date 11/30/2023; P2200772, P2200796, P2200830, Exp. Date 12/31/2023; P2201196, P2201198, Exp. Date 1/31/2024; P2200817, Exp. Date 12/31/2024; P2202610, Exp. Date 4/30/2025; P2203466, Exp. Date 5/31/2025;
- More code info
- —