Class II · Moderate risk Ongoing
Duloxetine D/R
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Duloxetine Delayed-Release Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
What was recalled
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
- Recalling firm
- Amerisource Health Services LLC
- NDC code
- 68001-414-04
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0100-2025
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Duloxetine recalls
See all
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Duloxetine DR Capsules
Reason CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
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