Reported Dec 11, 2024 · Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma…
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, 60 mg, Rx only, 1,000 count bottle
- Manufactured byAurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
- Lot codes and dates
- Lot
- expiry
DT6022159ADT6022167ADT6022168Aexp 11/30/2024Lot DT6023034A12/31/2024Lots DT6023050ADT6023051ADT6023063ADT6023067Aexp 01/31/2025Lots DT6023073ADT6023072Aexp 02/28/2025
- Amount recalled
- 8,561 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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