Duloxetine Delayed-Release Capsules recalled over manufacturing violations
- Recall date
- December 6, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Amerisource Health Services LLC recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limite…
- Recall number
- D-0158-2025
- FDA classification
- Class II
- Brand / firm
- Amerisource Health Services LLC
- Sold / distributed
- Nationwide in the USA
Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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