Status
Terminated
Drug Enforcement D-0474-2023
Failed Content Uniformity Specifications
Classification
Class III
Report Date
March 29, 2023
Termination Date
October 18, 2023
Product Information
- Product description
- Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86
- Product quantity
- 1,920 bottles
- Reason for recall
- Failed Content Uniformity Specifications
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- USA nationwide.
Location & Firm
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Address
-
2 Independence Way, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0474-2023
- Event ID
- 91871
- Recall initiation date
- March 9, 2023
- Center classification date
- March 22, 2023
- Code info
- Lot # DND1541A, Exp 08/2024
- More code info
- —