SUN PHARMACEUTICAL INDUSTRIES INC 2023-08-16 Health moderate FDA
Health · FDA · Recall #FDA-D-1082-2023
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun… Recall
Issued August 16, 2023 · SUN PHARMACEUTICAL INDUSTRIES INC
In August 2023, SUN PHARMACEUTICAL INDUSTRIES INC recalled the Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun…, a moderate health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Out of Specification result observed in content uniformity testing
What you should do
- 1 Stop using Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact SUN PHARMACEUTICAL INDUSTRIES INC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Health
- Recall date
- August 16, 2023
- Units affected
- Not reported
- Sold at
- Nationwide in the USA
- Recall number
- FDA-D-1082-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- SUN PHARMACEUTICAL INDUSTRIES INC has 34 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.