Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, 1000 Capsules, NDC 27241-098-10 - 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 st

Source: FDA | Recall date: 05/13/2026

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Affected product: Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, 1000 Capsules, NDC 27241-098-10

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.

Hazard: 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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