FDAHealthDecember 6, 2024
Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laborato
⚠️ CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 6, 2024
Nationwide in the USA
What's affected?
- Product
- Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04
- Lot code
- DT3023029A
Additional details
Lot DT3023029A Exp 02/28/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 21,262 bottles.
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