Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
Product description
Dofetilide Capsules 500 mcg (0.5 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 16729-492-12 UPC 3 16729 49212 6
Lot numbers, UPCs & expiration codes
Batches: P2101582, P2101661, P2101482, P2101686, Exp. Date 2/28/2023; P2102581, P2102598, Exp. Date 4/30/2023; P2103623, P2103653, P2103670, Exp. Date 5/31/2023; P2104463, P2104385, P2104386, P2104472, P2104709, P2104714, Exp. Date 6/30/2023; P2200797, P2200773, P2200831, Exp. Date 12/31/2023; P2201017, P2201081, P2201056, Exp. Date 1/31/2024; P2200819, Exp. Date 12/31/2024; P2202611, P2202616, Exp. Date 4/30/2025, P2203467, Exp. Date 5/31/2025
Where it was sold
United States including Puerto Rico and Canada
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0385-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 7, 2023
- FDA report date
- Mar 8, 2023
- Quantity
- 113,003 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Accord Healthcare, Inc.
Original FDA data
Every field from FDA enforcement report D-0385-2023, exactly as published.
Show all FDA fields
- City
- Durham
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 91657
- Address
- 1009 Slater Rd Ste 210B
- Code information
- Batches: P2101582, P2101661, P2101482, P2101686, Exp. Date 2/28/2023; P2102581, P2102598, Exp. Date 4/30/2023; P2103623, P2103653, P2103670, Exp. Date 5/31/2023; P2104463, P2104385, P2104386, P2104472, P2104709, P2104714, Exp. Date 6/30/2023; P2200797, P2200773, P2200831, Exp. Date 12/31/2023; P2201017, P2201081, P2201056, Exp. Date 1/31/2024; P2200819, Exp. Date 12/31/2024; P2202611, P2202616, Exp. Date 4/30/2025, P2203467, Exp. Date 5/31/2025
- Postal code
- 27703-8446
- Report date
- Mar 8, 2023
- Product type
- Drugs
- Recall number
- D-0385-2023
- Classification
- Class II
- Recalling firm
- Accord Healthcare, Inc.
- Product quantity
- 113,003 bottles
- Termination date
- Apr 22, 2024
- Reason for recall
- CGMP Deviations: recalling drug products following an FDA inspection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dofetilide Capsules 500 mcg (0.5 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 16729-492-12 UPC 3 16729 49212 6
- Distribution pattern
- United States including Puerto Rico and Canada
- Recall initiation date
- Feb 7, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 2, 2023