FDAHealthNovember 14, 2024
Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laborat
⚠️ CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Is this relevant to me?
- Geography
- PA, OH, PR
- Source agency
- FDA
- Category
- Health
- Published
- November 14, 2024
PA, OH, PR
What's affected?
- Product
- Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06
- Lot code
- DT2023001A
Additional details
Lots: DT2023001A, DT2023009A, exp date Jan 31, 2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 37,916 bottles.
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