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
Reported: March 29, 2023 Initiated: March 9, 2023 #D-0474-2023
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
Reason for Recall
Failed Content Uniformity Specifications
Details
- Recalling Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Units Affected
- 1,920 bottles
- Distribution
- USA nationwide.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 1,920 bottles.
Why was this product recalled? ▼
Failed Content Uniformity Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 29, 2023. Severity: Low. Recall number: D-0474-2023.
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