fda_recall · drug_recall · high
Ajanta Pharma Ltd. — Class II recall: Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: A…
- Event date
- 2026-05-13 00:00:00Z
- Observed
- 2026-07-09 22:51:42Z
- Source ID
- D-0516-2026
- Payload hash
- 4918560c2b9d84bed1b6a699…
Summary
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. Status: Ongoing.
Entities
Informational only. Not legal, financial, or medical advice.