Amerisource Health Services LLC 2024-12-11 Health serious FDA
Health · FDA · Recall #FDA-D-0100-2025
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04)… Recall
Issued December 11, 2024 · Amerisource Health Services LLC
In December 2024, Amerisource Health Services LLC recalled the Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04)…, a serious 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
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
What you should do
- 1 Stop using Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04)… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Amerisource Health Services LLC 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
- Amerisource Health Services LLC
- Category
- Health
- Recall date
- December 11, 2024
- Units affected
- Not reported
- Sold at
- PA, OH, PR
- Recall number
- FDA-D-0100-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Amerisource Health Services LLC has 20 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.