Home › Prescription medicine › Amerisource Health Services LLC — Duloxetine…
Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles
Do not stop taking this without speaking to your pharmacist or doctor.
What’s wrong
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
The Recall Registry rates this serious — FDA Class II: temporary or medically reversible health harm.
What to do
Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.
Who to contact: Recalling firm: Amerisource Health Services LLC
The product
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
Details
- Units affected
- 1,815 bottles
- Recall date
- December 6, 2024
- Brand
- Amerisource Health Services LLC
Nationwide in the USA
The official notice
This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.
Their exact wording: “Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08”
Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.
Filed under: Prescription medicine