D-1082-2023 Class III Terminated
FDA drug recall D-1082-2023 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on July 18, 2023 and is designated Class III. Reason for recall: Out of Specification result observed in content uniformity testing The recall status is terminated (terminated February 26, 2024). Affected quantity: 360 60-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 16, 2023
- Initiation Date
- July 18, 2023
- Termination Date
- February 26, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 360 60-count bottles
Product Description
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. NDC 47335-063-86
Reason for Recall
Out of Specification result observed in content uniformity testing
Distribution Pattern
Nationwide in the USA
Code Information
Lot: DNE0217A, Exp 01/2025