Ajanta Pharma Ltd. recalls
3 recalls.
- Duloxetine Delayed-Release Capsules recall (Ajanta Pharma Ltd.)
DrugClass IIReported May 13, 2026 · 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... - Duloxetine Delayed-Release Capsules recall (Ajanta Pharma Ltd.)
DrugClass IIReported May 13, 2026 · 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... - Duloxetine Delayed-Release Capsules recall (Ajanta Pharma Ltd.)
DrugClass IIReported May 13, 2026 · 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...