Healthnational✓ verified · 95%
Drug recall: Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03 — Ajanta Pharma Ltd.
- When
- · day precision
- Where
- Aurangabad, IN
- Category
- recall · drug_recall
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.
Involved actors & entities
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Correlated events
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