FDARecalled May 13, 2026 · #D-0516-2026
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.
Hazard
Class II — temporary health risk
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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. Classification: Class II Distribution: Nationwide within U.S
Product details
- Product
- Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.
- Type
- Drugs
- Manufacturer
- Ajanta Pharma Ltd.
- Model numbers
- PA10734
- UPCs
- —