Dofetilide Capsules 500 mcg recall
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
Why was Dofetilide Capsules 500 mcg recalled?
Out of Specification result observed in content uniformity testing
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?
Lot: DNE0217A, Exp 01/2025
- Product
- 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
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Quantity
- 360 60-count bottles
- Distribution
- Nationwide in the USA
- Recall date
- August 16, 2023
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)