FDAHealthDecember 6, 2024
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 Labo
⚠️ 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, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
- Lot code
- s
Additional details
Lots, expiry: Lot DT6022166A, exp 11/30/2024; Lot DT6023071A, exp 2/28/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1,815 bottles.
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