Dofetilide Capsules 250 mcg recall: CGMP Deviations
Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas…
Why was Dofetilide Capsules 250 mcg recalled?
CGMP Deviations: recalling drug products following an FDA inspection.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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;
- Product
- Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas…
- Recalling firm
- Accord Healthcare, Inc.
- Quantity
- 113,571 bottles
- Distribution
- United States including Puerto Rico and Canada
- Recall date
- March 8, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)