Reported Dec 11, 2024 · Ongoing
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC…
Amerisource Health Services LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amerisource Health Services LLC · 2550 John Glenn Ave Ste A · Columbus, OH · 43217-1188
Is this the product you have?
- Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles
- Manufactured byAurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
- Lot codes and dates
- a) 30 count; Lot
- expiry
DT3023019BDT3023020Aexp 01/31/2025 b) 1000 countLot
- expiry
DTB23098Aexp 08/31/2025
- Amount recalled
- 23,490 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
This product could cause temporary or reversible health problems — stop using it.
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