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Recall

Ajanta Pharma Ltd.: Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, 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. Product details: Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India

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Agency
FDA
Record ID
D-0514-2026
Canonical
https://claimwatch-mvp.vercel.app/item/ajanta-pharma-ltd-duloxetine-delayed-release-capsules-30-mg-rx-only-a-90-capsules/

What happened?

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. Product details: Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India

Who may be affected?

Nationwide within U.S

What should consumers do?

Affected quantity: 312,894 packs

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